Over-the-counter drug · OTC MONOGRAPH DRUG
Benadryl (Diphenhydramine hydrochloride) NDC 50580-226
Diphenhydramine hydrochloride 25 mg/1 · Tablet, Film coated · Oral · Kenvue Brands LLC
NDC codes
FDA NDC DirectoryProduct NDC (as listed)50580-226Labeler and product segments. Claims need a package NDC.
Product NDC at billing width50580-0226Add the package segment from the table below.
| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50580-226-12 | 5058002261250580022612 | 1 BLISTER PACK in 1 CARTON (50580-226-12) / 12 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Jun 11, 2025 | |
| 50580-226-20 | 5058002262050580022620 | 2 CARTON in 1 CARTON (50580-226-20) / 1 BOTTLE in 1 CARTON / 100 TABLET, FILM COATED in 1 BOTTLEMarketed from Jan 15, 2024 | |
| 50580-226-33 | 5058002263350580022633 | 3 CARTON in 1 CARTON (50580-226-33) / 1 BOTTLE in 1 CARTON / 48 TABLET, FILM COATED in 1 BOTTLEMarketed from Jul 28, 2025 | |
| 50580-226-50 | 5058002265050580022650 | 1 BOTTLE in 1 CARTON (50580-226-50) / 100 TABLET, FILM COATED in 1 BOTTLEMarketed from Jun 4, 2012 | |
| 50580-226-51 | 5058002265150580022651 | 2 BLISTER PACK in 1 CARTON (50580-226-51) / 12 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Jun 4, 2012 | |
| 50580-226-52 | 5058002265250580022652 | 4 BLISTER PACK in 1 CARTON (50580-226-52) / 12 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Jun 4, 2012 | |
| 50580-226-53 | 5058002265350580022653 | 2 TABLET, FILM COATED in 1 POUCH (50580-226-53)Marketed from Jun 4, 2012 | |
| 50580-226-54 | 5058002265450580022654 | 60 POUCH in 1 CARTON (50580-226-54) / 2 TABLET, FILM COATED in 1 POUCHMarketed from Jul 27, 2015 | |
| 50580-226-56 | 5058002265650580022656 | 3 CARTON in 1 PACKAGE (50580-226-56) / 4 BLISTER PACK in 1 CARTON / 12 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Feb 1, 2013 | |
| 50580-226-62 | 5058002266250580022662 | 4 POUCH in 1 CARTON (50580-226-62) / 2 TABLET, FILM COATED in 1 POUCHMarketed from Jan 2, 2017 | |
| 50580-226-70 | 5058002267050580022670 | 1 BOTTLE in 1 CARTON (50580-226-70) / 48 TABLET, FILM COATED in 1 BOTTLEMarketed from Jun 2, 2025 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Benadryl
- Generic name (nonproprietary)
- diphenhydramine hydrochloride
- Active ingredients
- Diphenhydramine hydrochloride — 25 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Kenvue Brands LLCNDC labeler code 50580
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication M 012
- Marketing start
- Listing expires
- Other FDA classes
- Histamine H1 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 50580-226_57a6b529-75db-f06e-e063-6294a90a7dd3SPL ID 57a6b529-75db-f06e-e063-6294a90a7dd3SPL set ID 702f9786-7ce9-43e4-921d-e1db09612127RxCUI 1049630, 1049632UNII TC2D6JAD40UPC 0300450171122
- Pharmacologic class
- Histamine-1 Receptor Antagonist
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N450580022612followed by a unit qualifier and the quantityPackage 50580-0226-12. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
Uses temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose sneezing itchy, watery eyes itching of the nose or throat temporarily relieves these symptoms due to the common cold: runny nose sneezing
Excerpt only. Read the full label for complete information.
About NDC 50580-226
- What is NDC 50580-226?
- 50580-226 is the product NDC for Benadryl (diphenhydramine hydrochloride), Diphenhydramine hydrochloride 25 mg/1 tablet, film coated, listed with the FDA by Kenvue Brands LLC. It has 11 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Benadryl (Diphenhydramine Hydrochloride).
- What is the active ingredient?
- Diphenhydramine hydrochloride.
- Who is the labeler?
- Kenvue Brands LLC, NDC labeler code 50580. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Benadryl?
- 7 other product NDCs are listed under this name. See all Benadryl NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Benadryl products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Benadryldiphenhydramine hydrochloride | Diphenhydramine hydrochloride 25 mg/1 | Tablet, Film coatedOral | Morning Star OTC | 53209-3001 | 53209-3001-02 |
| Benadryldiphenhydramine hydrochloride | Diphenhydramine hydrochloride 25 mg/1 | Tablet, Film coatedOral | Lil' Drug Store Products, Inc. | 66715-6506 | 66715-6506-02 |
| Benadryldiphenhydramine hydrochloride | Diphenhydramine hydrochloride 25 mg/1 | Tablet, Film coatedOral | Lil' Drug Store Products, Inc. | 66715-6406 | 66715-6406-0266715-6406-0766715-6406-08 |
| Benadryldiphenhydramine hydrochloride | — | Kit | Kenvue Brands LLC | 50580-370 | 50580-0370-01 |
| Benadryldiphenhydramine hydrochloride | Diphenhydramine hydrochloride 25 mg/1 | Tablet, Film coatedOral | Lil' Drug Store Products, Inc. | 66715-9706 | 66715-9706-0266715-9706-03 |
| Benadryldiphenhydramine hydrochloride | Diphenhydramine hydrochloride 25 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 71205-521 | 71205-0521-06 |
| Benadryldiphenhydramine hydrochloride | Diphenhydramine hydrochloride 25 mg/1 | Tablet, Film coatedOral | Select Consumer Group | 85237-1960 | 85237-1960-0185237-1960-0285237-1960-03+3 more |
Other NDCs under M 012
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Cough Reliefdextromethorphan hydrobromide | Dextromethorphan hydrobromide 15 mg/1 | Capsule, Liquid filledOral | Advanced Rx LLC | 80513-311 |
| TARGET Multi Symptom Flu Reliefacetaminophen, dextromethorphan hbr, and acetaminophen, chlorpheniramine maleate, dextromethorphan hbr | — | Kit | TARGET CORPORATION | 82442-559 |
| Geri-Dryl allergy reliefdiphenhydramine hcl | Diphenhydramine hydrochloride 25 mg/1 | Tablet, CoatedOral | VerityRx | 83939-0683 |
| Multi Symptom Cold and Multi Symptom Nighttime Cold Childrensdextromethorphan hbr, guaifenesin, phenylephrine hci, acetaminophen, diphenhydramine hci, phenylephrine hci | — | Kit | TARGET Corporation | 11673-420 |
| Welmedix HomeCare PRO Extra Strength Rapid Rash Reliefpetrolatum, zinc oxide | Petrolatum 49 g/100g; Zinc oxide 15 g/100g | CreamTopical | Welmedix LLC | 24330-410 |
| topcare nite time cold and fluacetaminophen, dextromethorphan hbr, doxylamine succinate | Acetaminophen 325 mg/1 + 2 more ingredients | Capsule, Liquid filledOral | Topco Associates LLC | 36800-143 |
| Allergy Childrensdiphenhydramine hydrochloride | Diphenhydramine hydrochloride 12.5 mg/5mL | LiquidOral | H E B | 37808-012 |
| Mucus Relief Cough Childrensdextromethorphan hbr, guaifensin | Dextromethorphan hydrobromide 5 mg/5mL; Guaifenesin 100 mg/5mL | LiquidOral | H E B | 37808-594 |
| Sunmark Chest Congestion Relief DM DMdextromethorphan hydrobromide / guaifenesin | Dextromethorphan hydrobromide 20 mg/1; Guaifenesin 400 mg/1 | TabletOral | Strategic Sourcing Services LLC | 49348-728 |
| Dual Action Honey Lemon Cough Suppressant Oral Anestheticmenthol | Menthol 8.3 mg/1 | LozengeOral | Ricola Ag | 54305-323 |
| Discount drug mart Extra Moisturizingoxymetazoline hydrochloride | Oxymetazoline hydrochloride .05 g/100mL | SprayNasal | DISCOUNT DRUG MART | 53943-720 |
| Mucus Reliefguaifenesin | Guaifenesin 400 mg/1 | TabletOral | Geri-Care Pharmaceuticals, Corp | 57896-714 |
| Robitussin Maximum Strength Severe Multi-Symptom Cough Cold Flu Nighttimeacetaminophen, diphenhydramine hcl | Acetaminophen 650 mg/20mL; Diphenhydramine hydrochloride 25 mg/20mL | LiquidOral | Haleon US Holdings LLC | 0031-0101 |
| Throat Comfort Orange Mint Cinnamon Dropsmenthol | Menthol 3.6 mg/1 | LozengeOral | Ricola USA Inc. | 63667-342 |
| Non-Drowsy Sinus Severe, Circle Kacetaminophen, guaifenesin, phenylephrine hcl caplet, film-coated | Guaifenesin 200 mg/1 + 2 more ingredients | Tablet, Film coatedOral | Lil' Drug Store products, Inc. | 66715-5632 |
| COLD, Flu and Sore Throatacetaminophen, guaifenesin, dextromethorphan hydrobromide, and phenylephrine hydrochloride | Acetaminophen 325 mg/1 + 3 more ingredients | Capsule, Liquid filledOral | Walgreens | 0363-9016 |
| Mucus Relief All in One Maximum Strengthacetaminophen, diphenhydramine hcl phenylephrine hcl | Acetaminophen 650 mg/20mL + 2 more ingredients | LiquidOral | Walgreens | 0363-9130 |
| Pyrilamine Maleate and Dextromethorphan Hydrobromide | Dextromethorphan hydrobromide 7.5 mg/5mL; Pyrilamine maleate 7.5 mg/5mL | LiquidOral | Westminster Pharmaceuticals, LLC | 69367-398 |
| Daytime Cold and Flu Relief Liquid Filled Softgelsacetaminophen, dextromethorphan hbr, phenylephrine hcl | Acetaminophen 325 mg/1 + 2 more ingredients | Capsule, Liquid filledOral | AptaPharma Inc. | 76281-604 |
| Cough Dropsmenthol | Menthol 5.8 mg/1 | PastilleOral | Topco Associates LLC | 76162-016 |
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