Over-the-counter drug · OTC MONOGRAPH DRUG
Diphenhydramine HCl NDC 71399-1027
Diphenhydramine hydrochloride 25 mg/1 · Capsule · Oral · Akron Pharma Inc.
NDC codes
FDA NDC DirectoryProduct NDC (as listed)71399-1027Labeler and product segments. Claims need a package NDC.
Product NDC at billing width71399-1027Add the package segment from the table below.
| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71399-1027-1 | 7139910270171399102701 | 100 CAPSULE in 1 BOTTLE (71399-1027-1)Marketed from Dec 6, 2024 | |
| 71399-1027-2 | 7139910270271399102702 | 1000 CAPSULE in 1 BOTTLE (71399-1027-2)Marketed from Dec 6, 2024 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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)
- Diphenhydramine HCl
- Generic name (nonproprietary)
- diphenhydramine hcl
- Active ingredients
- Diphenhydramine hydrochloride — 25 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Akron Pharma Inc.NDC labeler code 71399
- 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 71399-1027_35428d00-fa38-6055-e063-6394a90a7a78SPL ID 35428d00-fa38-6055-e063-6394a90a7a78SPL set ID 79a6b8c7-0e81-4a46-a854-31f449042709RxCUI 1020477, 1049909UNII TC2D6JAD40UPC 0371399102829, 0371399102812, 0371399102720
- 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
N471399102701followed by a unit qualifier and the quantityPackage 71399-1027-01. 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
Excerpt only. Read the full label for complete information.
About NDC 71399-1027
- What is NDC 71399-1027?
- 71399-1027 is the product NDC for Diphenhydramine HCl, Diphenhydramine hydrochloride 25 mg/1 capsule, listed with the FDA by Akron Pharma Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Diphenhydramine HCl.
- What is the active ingredient?
- Diphenhydramine hydrochloride.
- Who is the labeler?
- Akron Pharma Inc., NDC labeler code 71399. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Diphenhydramine HCl?
- 34 other product NDCs are listed under this name. See all Diphenhydramine HCl NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Diphenhydramine HCl products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Diphenhydramine HCLdiphenhydramine hydrochloride | Diphenhydramine hydrochloride 12.5 mg/5mL | SolutionOral | Redmont Pharmaceuticals, LLC | 71741-511 | 71741-0511-04 |
| Diphenhydramine HCldiphenhydramine hydrochloride | Diphenhydramine hydrochloride 25 mg/10mL | SolutionOral | Major Pharmaceuticals | 0904-7559 | 00904-7559-72 |
| Diphenhydramine HCldiphenhydramine hydrochloride | Diphenhydramine hydrochloride 12.5 mg/5mL | SolutionOral | Major Pharmaceuticals | 0904-7560 | 00904-7560-70 |
| Diphenhydramine HCl | Diphenhydramine hydrochloride 50 mg/1 | CapsuleOral | AARNA USA INC. | 82568-0005 | 82568-0005-0182568-0005-02 |
| Diphenhydramine HCl | Diphenhydramine hydrochloride 25 mg/1 | CapsuleOral | NuCare Pharmaceuticals,Inc. | 68071-3877 | 68071-3877-0368071-3877-0568071-3877-06 |
| Diphenhydramine HCl | Diphenhydramine hydrochloride 50 mg/1 | CapsuleOral | Akron Pharma Inc. | 71399-1028 | 71399-1028-0171399-1028-02 |
| Diphenhydramine HCl | Diphenhydramine hydrochloride 25 mg/1 | CapsuleOral | AARNA USA INC. | 82568-0004 | 82568-0004-0182568-0004-02 |
| Diphenhydramine HCldiphenhydramine hydrochloride | Diphenhydramine hydrochloride 12.5 mg/5mL | SolutionOral | American Health Packaging | 60687-829 | 60687-0829-86 |
| Diphenhydramine HCldiphenhydramine hydrochloride | Diphenhydramine hydrochloride 25 mg/10mL | SolutionOral | American Health Packaging | 60687-830 | 60687-0830-0860687-0830-56 |
| Diphenhydramine HCL | Diphenhydramine hydrochloride 12.5 mg/5mL | SolutionOral | Belleview Biosciences | 84447-103 | 84447-0103-0184447-0103-0484447-0103-16 |
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 |
|---|---|---|---|---|
| Daytime Cold and Flu Reliefacetaminohpen, dextromethorphan hbr, guaifenesin phenylephrine hcl | Acetaminophen 650 mg/30mL + 3 more ingredients | LiquidOral | The Kroger Co. | 30142-722 |
| Cold Fluacetaminophen, dextromethorphan hydrobromide, doxylamine succinate | — | Kit | HyVee Inc | 42507-598 |
| Allergy Reliefdiphenhydramine hcl | Diphenhydramine hydrochloride 25 mg/1 | Tablet, Film coatedOral | H E B | 37808-932 |
| Medi First Plus Cherry Cough Dropsmenthol | Menthol 7.6 mg/1 | LozengeOral | Unifirst First Aid Corporation | 47682-915 |
| Supress Adexbromopheniramine maleate, dextromethorphan hbr, phenylephrine hcl | Dexbrompheniramine maleate 1 mg/mL + 2 more ingredients | SyrupOral | Kramer Novis | 52083-057 |
| SAFETUSSIN Non Drowsy Cough plus chest congestiondextromethorphan hydrobromide, and guaifenesin | Dextromethorphan hydrobromide 10 mg/1; Guaifenesin 200 mg/1 | TabletOral | KRAMER LABORATORIES | 55505-231 |
| Tusnel-DM Pediatricdextromethorphan hbr, guaifenesin, phenylephrine hcl | Dextromethorphan hydrobromide 2.5 mg/mL + 2 more ingredients | Solution/ dropsOral | LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION | 54859-606 |
| Dg Health Cold Flu Reliefacetaminophen, dextromethorphan hydrobromide, doxylamine succinate | Acetaminophen 325 mg/15mL + 2 more ingredients | SolutionOral | Dolgencorp Inc | 55910-753 |
| Acetaminophen and Diphenhydramine citrate | Acetaminophen 500 mg/1; Diphenhydramine citrate 38 mg/1 | TabletOral | InvaTech Pharma Solutions LLC | 57631-010 |
| MUCINEX SINUS-MAX SEVERE CONGESTION RELIEF SINUS and ALLERGYoxymetazoline hydrochloride | Oxymetazoline hydrochloride .05 g/100mL | SolutionNasal | Reckitt Benckiser LLC | 63824-120 |
| Vicks Sinex SEVERE CONGESTIONoxymetazoline hydrochloride | Oxymetazoline hydrochloride .0005 g/mL | SprayNasal | Procter & Gamble Manufacturing GmbH | 64336-002 |
| Walgreens Honey Lemon Cough Dropsmenthol | Menthol 7.5 mg/1 | LozengeOral | Walgreens | 0363-9959 |
| Tesalon Jarabe Adultoacetaminophen, dextromethorphan hbr, guaifenesin usp, phenylephrine hcl | Acetaminophen 500 mg/20mL + 3 more ingredients | SyrupOral | OPMX LLC | 69729-787 |
| Guaifenesin | Guaifenesin 400 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-9616 |
| Cold Head Congestion Severeacetaminophen, guaifenesin, and phenylephrine hydrochloride | Acetaminophen 325 mg/1 + 2 more ingredients | Tablet, CoatedOral | Harris Teeter | 72036-175 |
| DG Health Cough Drops Cherry Flavormenthol | Menthol 5.8 mg/1 | LozengeTopical | Dollar General Corporation | 75712-005 |
| Nuvicare NightTime Cold and Flu Softgelacetaminophen, dextromethorphan hydrobromide, doxylamine succinate | Acetaminophen 325 mg/1 + 2 more ingredients | Capsule, Liquid filledOral | NUVICARE LLC | 84324-019 |
| Quality Choice Mucus Reliefguaifenesin | Guaifenesin 400 mg/1 | TabletOral | Chain Drug Marketing Association | 83324-194 |
| Diphenhydramine HCl | Diphenhydramine hydrochloride 12.5 mg/5mL | SolutionOral | Major Pharmaceuticals | 0904-6985 |
| severe cold and flu reliefacetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride | Acetaminophen 325 mg/15mL + 3 more ingredients | SolutionOral | Rite Aid Corporation | 11822-3120 |
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