Over-the-counter drug · OTC MONOGRAPH DRUG
Diphenhydramine HCL NDC 84447-103
Diphenhydramine hydrochloride 12.5 mg/5mL · Solution · Oral · Belleview Biosciences
NDC codes
FDA NDC DirectoryProduct NDC (as listed)84447-103Labeler and product segments. Claims need a package NDC.
Product NDC at billing width84447-0103Add the package segment from the table below.
| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 84447-103-01 | 8444701030184447010301 | 200000 mL in 1 DRUM (84447-103-01)Marketed from Jul 20, 2024 | |
| 84447-103-04 | 8444701030484447010304 | 118 mL in 1 BOTTLE, PLASTIC (84447-103-04)Marketed from Jul 20, 2024 | |
| 84447-103-16 | 8444701031684447010316 | 473 mL in 1 BOTTLE, PLASTIC (84447-103-16)Marketed from Jul 20, 2024 |
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)
- Diphenhydramine HCL
- Generic name (nonproprietary)
- diphenhydramine hcl
- Active ingredients
- Diphenhydramine hydrochloride — 12.5 mg/5mL
- Dosage form
- Solution
- Route
- Oral
- Labeler
- Belleview BiosciencesNDC labeler code 84447
- 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 84447-103_3765beab-e853-b34f-e063-6394a90ac9d5SPL ID 3765beab-e853-b34f-e063-6394a90ac9d5SPL set ID 1db57d86-39f0-f8ca-e063-6394a90a6397RxCUI 1049906UNII TC2D6JAD40
- 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
N484447010301followed by a unit qualifier and the quantityPackage 84447-0103-01. 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 ■ Temporarily relieves these symptoms due to the common cold: ■ runny nose ■ sneezing
Excerpt only. Read the full label for complete information.
About NDC 84447-103
- What is NDC 84447-103?
- 84447-103 is the product NDC for Diphenhydramine HCL, Diphenhydramine hydrochloride 12.5 mg/5mL solution, listed with the FDA by Belleview Biosciences. It has 3 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?
- Belleview Biosciences, NDC labeler code 84447. 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 25 mg/1 | CapsuleOral | Akron Pharma Inc. | 71399-1027 | 71399-1027-0171399-1027-02 |
| 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 |
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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