Over-the-counter drug · OTC MONOGRAPH DRUG
Diphenhydramine Hydrochloride NDC 71679-308
Diphenhydramine hydrochloride 25 mg/1 · Tablet, Film coated · Oral · Health Pharma USA LLC
NDC codes
FDA NDC DirectoryProduct NDC (as listed)71679-308Labeler and product segments. Claims need a package NDC.
Product NDC at billing width71679-0308Add the package segment from the table below.
| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71679-308-00 | 7167903080071679030800 | 100000 TABLET, FILM COATED in 1 BOTTLE (71679-308-00)Marketed from Jun 27, 2026 |
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 Hydrochloride
- Generic name (nonproprietary)
- diphenhydramine hydrochloride
- Active ingredients
- Diphenhydramine hydrochloride — 25 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Health Pharma USA LLCNDC labeler code 71679
- 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 71679-308_5535aeab-2fdb-8e48-e063-6294a90ab610SPL ID 5535aeab-2fdb-8e48-e063-6294a90ab610SPL set ID 31755678-825c-b84a-e063-6294a90a5a83RxCUI 1049630UNII 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
N471679030800followed by a unit qualifier and the quantityPackage 71679-0308-00. 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 Sneezing, runny nose, itchy, watery eyes, and itchy throat.
Excerpt only. Read the full label for complete information.
About NDC 71679-308
- What is NDC 71679-308?
- 71679-308 is the product NDC for Diphenhydramine Hydrochloride, Diphenhydramine hydrochloride 25 mg/1 tablet, film coated, listed with the FDA by Health Pharma USA LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Diphenhydramine Hydrochloride.
- What is the active ingredient?
- Diphenhydramine hydrochloride.
- Who is the labeler?
- Health Pharma USA LLC, NDC labeler code 71679. 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 Hydrochloride?
- 80 other product NDCs are listed under this name. See all Diphenhydramine Hydrochloride NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Diphenhydramine Hydrochloride 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 Hydrochloride | Diphenhydramine hydrochloride 25 mg/1 | TabletOral | Cardinal Health 107, LLC | 55154-1589 | 55154-1589-00 |
| Diphenhydramine hydrochloride | Diphenhydramine hydrochloride 12.5 mg/5mL | SolutionOral | Camber Pharmaceuticals, Inc. | 31722-600 | 31722-0600-1131722-0600-31 |
| Diphenhydramine hydrochloride | Diphenhydramine hydrochloride 25 mg/10mL | SolutionOral | Camber Pharmaceuticals, Inc. | 31722-601 | 31722-0601-31 |
| Diphenhydramine Hydrochloride | Diphenhydramine hydrochloride 50 mg/mL | InjectionIntramuscular, Intravenous | REMEDYREPACK INC. | 70518-4536 | 70518-4536-00 |
| Diphenhydramine Hydrochloride | Diphenhydramine hydrochloride 50 mg/mL | InjectionIntramuscular, Intravenous | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-263 | 23155-0263-31 |
| Diphenhydramine Hydrochloride | Diphenhydramine hydrochloride 50 mg/mL | InjectionIntramuscular, Intravenous | Micro Labs Limited | 42571-511 | 42571-0511-56 |
| Diphenhydramine hydrochloride | Diphenhydramine hydrochloride 50 mg/mL | InjectionIntramuscular, Intravenous | REMEDYREPACK INC. | 70518-4455 | 70518-4455-00 |
| Diphenhydramine Hydrochloride | Diphenhydramine hydrochloride 50 mg/1 | Capsule, Liquid filledOral | Prodose, Inc. | 68210-5057 | 68210-5057-01 |
| Diphenhydramine Hydrochloride | Diphenhydramine hydrochloride 50 mg/mL | InjectionIntramuscular, Intravenous | Medical Purchasing Solutions, LLC | 71872-7373 | 71872-7373-01 |
| Diphenhydramine Hydrochloride | Diphenhydramine hydrochloride 50 mg/mL | InjectionIntramuscular, Intravenous | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-264 | 23155-0264-41 |
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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