Over-the-counter drug · OTC MONOGRAPH FINAL
Allergy (Diphenhydramine hydrochloride) NDC 76168-121
Diphenhydramine hydrochloride 25 mg/1 · Tablet · Oral · Velocity Pharma LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 76168-121-12 | 7616801211276168012112 | 100 CARTON in 1 BOTTLE (76168-121-12) / 1 TABLET in 1 CARTONMarketed from May 14, 2018 |
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)
- Allergy
- Generic name (nonproprietary)
- diphenhydramine hydrochloride
- Active ingredients
- Diphenhydramine hydrochloride — 25 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Velocity Pharma LLCNDC labeler code 76168
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph (final)Application part341
- Marketing start
- Listing expires
- Other FDA classes
- Histamine H1 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 76168-121_6c30ec6a-4c24-d604-e053-2a91aa0ac869SPL ID 6c30ec6a-4c24-d604-e053-2a91aa0ac869SPL set ID 73e4f21c-e5ec-42c9-9ec8-118479857057RxCUI 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
N476168012112followed by a unit qualifier and the quantityPackage 76168-0121-12. 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 of hay fever or other upper respiratory allergies: runny nose itching of the nose or throat sneezing itchy, watery eyes temporarily relieves these symptoms due to the common cold: runny nose sneezing
Excerpt only. Read the full label for complete information.
About NDC 76168-121
- What is NDC 76168-121?
- 76168-121 is the product NDC for Allergy (diphenhydramine hydrochloride), Diphenhydramine hydrochloride 25 mg/1 tablet, listed with the FDA by Velocity Pharma LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Allergy (Diphenhydramine Hydrochloride).
- What is the active ingredient?
- Diphenhydramine hydrochloride.
- Who is the labeler?
- Velocity Pharma LLC, NDC labeler code 76168. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Allergy?
- 25 other product NDCs are listed under this name. See all Allergy NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Allergy products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Allergymometasone furoate | Mometasone furoate monohydrate 50 ug/1 | Spray, MeteredNasal | Amazon.com Services LLC | 72288-506 | 72288-0506-02 |
| Allergyfexofenadine hydrochloride | Fexofenadine hydrochloride 180 mg/1 | Tablet, Film coatedOral | Amazon.com Services LLC | 72288-716 | 72288-0716-0072288-0716-39 |
| allergymometasone furoate monohydrate | Mometasone furoate monohydrate 50 ug/1 | Spray, MeteredNasal | HyVee Inc | 42507-182 | 42507-0182-02 |
| Allergydiphenhydramine hcl | Diphenhydramine hydrochloride 25 mg/1 | Tablet, Film coatedOral | Publix Super Markets Inc | 56062-923 | 56062-0923-0856062-0923-12 |
| Allergymometasone furoate monohydrate | Mometasone furoate monohydrate 50 ug/1 | Spray, MeteredNasal | Rite Aid Corporation | 11822-7099 | 11822-7099-01 |
| allergymometasone furoate monohydrate | Mometasone furoate monohydrate 50 ug/1 | Spray, MeteredNasal | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 51316-117 | 51316-0117-11 |
| Allergyallium cepa, ambrosia, arsenicum alb, carbo veg, euphrasia, nux vom, phosphorus, pulsatilla, sulphur, solidago | Onion 30 [hp_C]/mL + 8 more ingredients | LiquidOral | Zorex International | 81825-0007 | 81825-0007-01 |
| Allergydiphenhydramine hydrochloride | Diphenhydramine hydrochloride 25 mg/1 | Tablet, Film coatedOral | Kroger Company | 41226-160 | 41226-0160-0141226-0160-4041226-0160-42 |
| Allergycetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | Tablet, Film coatedOral | Kroger Company | 41226-692 | 41226-0692-1441226-0692-6541226-0692-70 |
| Allergyallium sat, anacardium, apis mel, gambogia, merc solub, nat carb, nitricum ac, nux vom, phosphorus, pulsatilla, sulphur | Garlic 12 [hp_X]/59.1mL + 10 more ingredients | LiquidOral | Net Remedies | 61626-0109 | 61626-0109-04 |
Other NDCs under part341
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 |
|---|---|---|---|---|
| Pseudo Time PEphenylephrine hchloride | Phenylephrine hydrochloride 10 mg/1 | Tablet, Film coatedOral | TIME CAP LABORATORIES, INC. | 49483-234 |
| Allergy Timechlorpheniramine maleate | Chlorpheniramine maleate 4 mg/1 | TabletOral | Time Cap Labs Inc | 49483-242 |
| Diphenhydramine Hydrochloride | Diphenhydramine hydrochloride 25 mg/1 | Tablet, CoatedOral | Time-Cap Labs, Inc | 49483-329 |
| CVS Health Sinus Reliefoxymetazoline hydrochloride | Oxymetazoline hydrochloride .0005 g/mL | SprayNasal | CVS Pharmacy,Inc. | 59779-787 |
| Severe Cold Head Congestionacetaminophen, guaifenesin, and phenylephrine hydrochloride | Acetaminophen 325 mg/1 + 2 more ingredients | Tablet, CoatedOral | Marc Glassman, Inc. | 68998-175 |
| CVS Health Childrens Allergy Reliefdiphenhydramine hydrochloride | Diphenhydramine hydrochloride 12.5 mg/5mL | LiquidOral | CVS Pharmacy,Inc. | 59779-793 |
| CVS Health Four Actions Nasal Decongestantphenylephrine hydrochloride | Phenylephrine hydrochloride 10 mg/mL | SprayNasal | CVS Pharmacy,Inc. | 59779-838 |
| Tussin CFdextromethorphan hbr guaifenesin phenylephrine hcl | Dextromethorphan hydrobromide 20 mg/10mL + 2 more ingredients | SolutionOral | Strategic Sourcing Services | 70677-1187 |
| Tussinguaifenesin | Guaifenesin 200 mg/10mL | SolutionOral | Strategic Sourcing Services | 70677-1186 |
| Discount Drug Mart Value Vapor Steamcamphor (synthetic) | Camphor (Synthetic) .623 g/10mL | LiquidRespiratory (Inhalation) | Drug Mart | 53943-256 |
| Pressure Pain Mucus PEacetaminophen, guaifenesin, and phenylephrine hydrochloride | Acetaminophen 325 mg/1 + 2 more ingredients | Tablet, CoatedOral | Chain Drug Marketing Association | 63868-747 |
| NightTime Cold and Fluacetaminophen,dextromethorphan,doxylamine | Acetaminophen 325 mg/1 + 2 more ingredients | Capsule, Liquid filledOral | Velocity Pharma | 76168-056 |
| Nightime Sleep Aiddiphenhydramine | Diphenhydramine hydrochloride 50 mg/1 | Capsule, Liquid filledOral | Velocity Pharma | 76168-065 |
| Diphenhydramine Hydrochloride | Diphenhydramine hydrochloride 25 mg/1 | CapsuleOral | Epic Pharma, LLC | 42806-648 |
| Diphenhydramine Hydrochloride | Diphenhydramine hydrochloride 50 mg/1 | CapsuleOral | Epic Pharma, LLC | 42806-649 |
| Pi Yuan Chinnaphazoline hydrochloride | Naphazoline hydrochloride 1 mg/1 | Solution/ dropsNasal | International Nature Nutraceuticals | 51367-035 |
| Sugar Free Cherry Cough Dropsmenthol | Menthol 5.8 1/1 | LozengeOral | Army & Air Force Exchange Service | 55301-038 |
| Walgreens Adult Nighttime Wal Tussin DM Max Maximum Strengthdextromethorphan hbr, doxylamine succinate | Dextromethorphan hydrobromide 30 mg/20mL; Doxylamine succinate 12.5 mg/20mL | SolutionOral | WALGREEN CO. | 0363-0758 |
| Best Choice Effervescent Cold Reliefaspirin, chlorpheniramine maleate, phenylephrine bitartrate | Aspirin 325 mg/1 + 2 more ingredients | Tablet, EffervescentOral | Valu Merchandiser Company | 63941-873 |
| CVS Health Nighttime Sleep Aiddiphenhydramine hydrochloride | Diphenhydramine hydrochloride 50 mg/30mL | LiquidOral | CVS Pharmacy,Inc. | 69842-753 |
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