Over-the-counter drug · OTC MONOGRAPH DRUG
Allergy Relief Childrens (Diphenhydramine hcl) NDC 0904-7533
Diphenhydramine hydrochloride 12.5 mg/5mL · Solution · Oral · Major Pharmaceuticals
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0904-7533-15 | 00904753315 | 473 mL in 1 BOTTLE, PLASTIC (0904-7533-15)Marketed from Mar 7, 2025 | |
| 0904-7533-20 | 00904753320 | 1 BOTTLE, PLASTIC in 1 CARTON (0904-7533-20) / 118 mL in 1 BOTTLE, PLASTICMarketed from Mar 7, 2025 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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 Relief ChildrensSuffix: Childrens
- Generic name (nonproprietary)
- diphenhydramine hcl
- Active ingredients
- Diphenhydramine hydrochloride — 12.5 mg/5mL
- Dosage form
- Solution
- Route
- Oral
- Labeler
- Major PharmaceuticalsNDC labeler code 0904
- 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 0904-7533_3648f1ee-b2d4-41d9-ac39-c8ec482a6e92SPL ID 3648f1ee-b2d4-41d9-ac39-c8ec482a6e92SPL set ID 3a976e90-c6af-4414-984e-9987158c9e98RxCUI 1049906UNII TC2D6JAD40UPC 0309047533152
- 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
N400904753315followed by a unit qualifier and the quantityPackage 00904-7533-15. 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 0904-7533
- What is NDC 0904-7533?
- 0904-7533 is the product NDC for Allergy Relief Childrens (diphenhydramine hcl), Diphenhydramine hydrochloride 12.5 mg/5mL solution, listed with the FDA by Major Pharmaceuticals. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Allergy Relief Childrens (Diphenhydramine HCl).
- What is the active ingredient?
- Diphenhydramine hydrochloride.
- Who is the labeler?
- Major Pharmaceuticals, NDC labeler code 0904. 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 Relief Childrens?
- 12 other product NDCs are listed under this name. See all Allergy Relief Childrens NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Allergy Relief Childrens products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Allergy Relief Childrensdiphenhydramine hcl | Diphenhydramine hydrochloride 12.5 mg/5mL | SolutionOral | Chain Drug Marketing Association, Inc. | 83324-326 | 83324-0326-04 |
| Allergy Relief Childrensdiphenhydramine hcl | Diphenhydramine hydrochloride 12.5 mg/5mL | SolutionOral | WALMART INC. | 79903-368 | 79903-0368-04 |
| Allergy Relief Childrensdiphenhydramine hcl | Diphenhydramine hydrochloride 12.5 mg/5mL | SolutionOral | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 51316-180 | 51316-0180-1951316-0180-36 |
| Allergy Relief Childrensdiphenhydramine hcl | Diphenhydramine hydrochloride 12.5 mg/5mL | SolutionOral | A-S Medication Solutions | 50090-7824 | 50090-7824-00 |
| Allergy Relief Childrensdiphenhydramine hcl | Diphenhydramine hydrochloride 12.5 mg/5mL | SolutionOral | L.N.K. International, Inc. | 50844-015 | 50844-0015-19 |
| Allergy Relief Childrensdiphenhydramine hcl | Diphenhydramine hydrochloride 12.5 mg/5mL | SolutionOral | Family Dollar Services Inc | 55319-315 | 55319-0315-36 |
| Allergy Relief Childrensdiphenhydramine hcl | Diphenhydramine hydrochloride 12.5 mg/5mL | SolutionOral | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 51316-150 | 51316-0150-19 |
| Allergy Relief childrensdiphenhydramine hcl | Diphenhydramine hydrochloride 12.5 mg/5mL | SolutionOral | WALMART INC. | 79903-175 | 79903-0175-08 |
| allergy relief childrenscetirizine hcl | Cetirizine hydrochloride 5 mg/5mL | SolutionOral | CVS Pharmacy | 59779-837 | 59779-0837-2659779-0837-34 |
| allergy relief childrensdiphenhydramine hcl | Diphenhydramine hydrochloride 12.5 mg/5mL | SolutionOral | CVS Pharmacy | 59779-874 | 59779-0874-26 |
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 |
|---|---|---|---|---|
| equate allergy reliefdiphenhydramine hydrochloride | Diphenhydramine hydrochloride 25 mg/1 | TabletOral | WALMART INC. | 79903-297 |
| Nighttime Severe Cold and Fluacetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl | Doxylamine succinate 12.5 mg/30mL + 3 more ingredients | LiquidOral | Grocery Outlet, Inc. | 85828-775 |
| Complete Cold Reliefacetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl | Acetaminophen 650 mg/20mL + 3 more ingredients | SolutionOral | Belmora LLC | 27854-299 |
| Allergy Reliefdiphenhydramine hcl 25 mg | Diphenhydramine hydrochloride 25 mg/1 | Tablet, Film coatedOral | Lil' Drug Store Products, Inc. | 29485-9285 |
| Sinus Relief Daytime Nighttimeacetaminophen, diphenhydramine hcl, guaifenesin, phenylephrine hcl | — | Kit | Kroger Company | 30142-616 |
| nasal decongestantoxymetazoline hcl | Oxymetazoline hydrochloride .05 g/100mL | SprayNasal | A-S Medication Solutions | 50090-5281 |
| Discount drug mart Extra Moisturizingoxymetazoline hydrochloride | Oxymetazoline hydrochloride .05 g/100mL | SprayNasal | DISCOUNT DRUG MART | 53943-720 |
| Throat Comfort Orange Mint Cinnamon Dropsmenthol | Menthol 3.6 mg/1 | LozengeOral | Ricola Ag | 54305-342 |
| Geri-Tussin DMdextromethorphan hbr, guaifenesin | Dextromethorphan hydrobromide 10 mg/5mL; Guaifenesin 100 mg/5mL | LiquidOral | Geri-Care Pharmaceuticals, Corp | 57896-661 |
| Childrens Cough and Coldchlorpheniramine maleate, dextrometrorphan hbr | Chlorpheniramine maleate 2 mg/10mL; Dextromethorphan hydrobromide 15 mg/10mL | LiquidOral | FAMILY DOLLAR SERVICES INC | 55319-754 |
| Sinus Pressure and Pain Maximum Strengthacetaminophen, phenylephrine hcl | Acetaminophen 325 mg/1; Phenylephrine hydrochloride 5 mg/1 | TabletOral | DOLGENCORP, LLC | 55910-925 |
| Giltuss Sinus and Chest Congestionguaifenesin, phenylephrine hcl | Guaifenesin 388 mg/1; Phenylephrine hydrochloride 10 mg/1 | TabletOral | Gil Pharmaceutical Corp | 58552-332 |
| Robitussin Day and Night Cough Relief Value Packdextromethorphan hydrobromide, guaifenesin, chlorpheniramine maleate | — | Kit | Haleon US Holdings LLC | 0031-2099 |
| Alka-Seltzer Plus Severe Cough Mucus and Congestion Liquid Gelsalka-seltzer plus severe cough mucus and congestion | Phenylephrine hydrochloride 5 mg/1 + 3 more ingredients | Capsule, Liquid filledOral | Bayer HealthCare LLC. | 0280-0505 |
| Mucinex Childrens FreeFrom Multi-Symptom Cold and Stuffy Nosedextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride | Dextromethorphan hydrobromide 5 mg/5mL + 2 more ingredients | SolutionOral | Reckitt Benckiser LLC | 63824-956 |
| Major Nasal Decongestantoxymetazoline hydrochloride | Oxymetazoline hydrochloride .5 mg/mL | SprayNasal | NuCare Pharmaceuticals, Inc. | 68071-3858 |
| Allergy Reliefdiphenhydramine hcl | Diphenhydramine hydrochloride 50 mg/1 | Tablet, Film coatedOral | Walgreen Company | 0363-1799 |
| nighttime severe cold and fluacetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride | Acetaminophen 325 mg/15mL + 3 more ingredients | SolutionOral | Walgreen Company | 0363-2029 |
| Allergy Reliefdiphenhydramine hcl | Diphenhydramine hydrochloride 50 mg/1 | TabletOral | BIONPHARMA INC. | 69452-445 |
| Multi Symptom Cold and Multi Symptom Nighttime Cold Childrensdextromethorphan hbr, guaifenesin, phenylephrine hci, acetaminophen, diphenhydramine hci, phenylephrine hci | — | Kit | CVS Pharmacy | 69842-820 |
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