Over-the-counter drug · OTC MONOGRAPH DRUG
careone allergy relief (Diphenhydramine hydrochloride) NDC 41520-778
Diphenhydramine hydrochloride 25 mg/1 · Tablet · Oral · American Sales Company
NDC codes
FDA NDC DirectoryProduct NDC (as listed)41520-778Labeler and product segments. Claims need a package NDC.
Product NDC at billing width41520-0778Add the package segment from the table below.
| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 41520-778-78 | 4152007787841520077878 | 1 BOTTLE in 1 CARTON (41520-778-78) / 100 TABLET in 1 BOTTLEMarketed from Sep 21, 2017 |
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)
- careone allergy relief
- Generic name (nonproprietary)
- diphenhydramine hydrochloride
- Active ingredients
- Diphenhydramine hydrochloride — 25 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- American Sales CompanyNDC labeler code 41520
- 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 41520-778_703c7305-4a5a-4d22-ae35-db8657dccf8cSPL ID 703c7305-4a5a-4d22-ae35-db8657dccf8cSPL set ID ed4038fc-ab39-4567-9961-2b390b91b126RxCUI 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
N441520077878followed by a unit qualifier and the quantityPackage 41520-0778-78. 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 of the common cold: • runny nose • sneezing
Excerpt only. Read the full label for complete information.
About NDC 41520-778
- What is NDC 41520-778?
- 41520-778 is the product NDC for careone allergy relief (diphenhydramine hydrochloride), Diphenhydramine hydrochloride 25 mg/1 tablet, listed with the FDA by American Sales Company. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- careone allergy relief (Diphenhydramine Hydrochloride).
- What is the active ingredient?
- Diphenhydramine hydrochloride.
- Who is the labeler?
- American Sales Company, NDC labeler code 41520. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for careone allergy relief?
- 7 other product NDCs are listed under this name. See all careone allergy relief NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other careone allergy relief products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| careone allergy reliefcetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | Capsule, Liquid filledOral | Retail Business Services, LLC | 72476-623 | 72476-0623-63 |
| careone allergy relieffexofenadine hydrochloride | Fexofenadine hydrochloride 180 mg/1 | Tablet, Film coatedOral | Retail Business Services, LLC | 72476-847 | 72476-0847-2272476-0847-95 |
| careone allergy reliefloratadine | Loratadine 10 mg/1 | Tablet, Orally disintegratingOral | American Sales Company | 41520-510 | 41520-0510-65 |
| CareOne Allergy Reliefcetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | Capsule, Liquid filledOral | American Sales Company | 41520-715 | 41520-0715-63 |
| CareOne Allergy Relieffexofenadine hcl | Fexofenadine hydrochloride 180 mg/1 | Tablet, Film coatedOral | American Sales Company | 41520-229 | 41520-0229-2241520-0229-3941520-0229-95 |
| CareOne Allergy Reliefcetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | Tablet, Film coatedOral | American Sales Company | 41520-781 | 41520-0781-0641520-0781-3941520-0781-66+1 more |
| CareOne Allergy Relieffluticasone propionate | Fluticasone propionate 50 ug/1 | Spray, MeteredNasal | American Sales Company | 41520-703 | 41520-0703-0141520-0703-0241520-0703-03 |
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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