Childrens Allergy
- Product NDC
- 63868-370
- 11-digit product format
- 638680370
- Labeler code
- 63868
- Product ID
- 63868-370_efac59d9-21aa-4627-876f-12a5fe16165b
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Diphenhydramine Hydrochloride
- Dosage form
- LIQUID
- Route
- ORAL
- Labeler
- QUALITY CHOICE (Chain Drug Marketing Association)
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2014-05-30
- Marketing end
- 2026-12-28
- Substance
- DIPHENHYDRAMINE HYDROCHLORIDE
- Active strength
- 12.5 mg/5mL
- Pharmacologic classes
- Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
- NDC exclude flag
- No
- Current FDA listing
- Yes
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Childrens Allergy
Active Ingredients#
| Ingredient | Strength |
|---|---|
| DIPHENHYDRAMINE HYDROCHLORIDE | 12.5 mg/5mL |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 0e2e0f88-b076-afe1-4bdd-32bca4375bec | Product name | 3 | 20250127 |
| 3e48c9c4-918d-5d23-2f0b-d2398b06be54 | Product name | 1 | 20140508 |
| 865c72dd-0d94-daac-f728-ddd4ded2a79e | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 63868-370-04 | Childrens Allergy | 1 in 1 BOX | LIQUID | 1 | 7 | |
| 63868-370-04 | Childrens Allergy | 118 mL in 1 BOTTLE | LIQUID | 118 | 7 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 63868-370-04 | ML - Milliliter | 63868-370 | 33df79f1-77ca-40ba-9508-19cfff3b1f2a | 1 | 2021-04-08 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Allergy Relief | DIPHENHYDRAMINE HCL | L.N.K. International, Inc. | db264d2f-bf81-4da2-8595-2bfa1e4ba2f1 | 2026-05-18 | Warnings | M012 |
| equate nighttime cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE | Wal-Mart Stores Inc | b8fc9b0e-8ab7-46e6-9fd9-18f8d4a14b5c | 2026-05-15 | Warnings | M012 |
| good neighbor pharmacy cold and cough | BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Amerisource Bergen | da91e6b6-32ff-44fd-afce-33ea9549554b | 2026-05-15 | Warnings | M012 |
| Antihistamine | DIPHENHYDRAMINE HCL | Gendose Pharmaceuticals, LLC | 847cdee8-410f-4ff3-9245-976ed6f4c776 | 2026-05-15 | Warnings | M012 |
| Antihistamine | DIPHENHYDRAMINE HCL | Gendose Pharmaceuticals, LLC | d3b2f300-d919-44cd-ab71-b74b5bdfd977 | 2026-05-15 | Warnings | M012 |
| ONESSIP DAY TIME KIDS COLD AND COUGH PLUS FEVER | ACETAMINOPHEN 325 MG AND DEXTROMETHORPHAN HBR 10 MG ORAL LIQUID DAY TIME KIDS | MEDWISE LIFESCIENCES INC. | 51d52ce4-98c4-2b9b-e063-6294a90ade44 | 2026-05-15 | Warnings | M012 |
| Curewell Tussin DM | DEXTROMETHORPHAN, GUAIFENESIN | RMT HEALTH LLC | 4fe9ad93-cdc4-b4df-e063-6294a90a90ae | 2026-05-15 | Warnings | M012 |
| CounterAct Cough Drops Orchard Cherry | MENTHOL | Melaleuca, Inc. | 6049842c-d763-4a91-a225-976ed74e1693 | 2026-05-15 | Warnings | M012 |
| CounterAct Cough Drops Honey Lemon | MENTHOL | Melaleuca, Inc. | 84ac3489-9d64-401f-ab78-715af4de5440 | 2026-05-15 | Warnings | M012 |
| ALKA SELTZER COLD Cold Flu and Congestion Maximum Strength Day Night Fast Gels | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE | Bayer HealthCare LLC. | 51e03b5b-b05a-07c1-e063-6394a90ab201 | 2026-05-15 | Warnings | M012 |
| Sinus Congestion and Pain Relief Non-Drowsy/Daytime | ACETAMINOPHEN, GUAIFENESIN AND PHENYLEPHRINE HCL | Rite Aid Corporation | 38d73a1e-ac78-4f67-9291-bb48ab80306e | 2026-05-15 | Warnings | M012 |
| Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR | WALMART INC. | 071615ba-f50a-4d2a-a358-43140bccce72 | 2026-05-14 | Warnings | M012 |
| Severe Cold and Flu Nighttime Daytime | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | HyVee Inc | d4bcfabb-a054-4f53-8dc9-d361a03558b8 | 2026-05-14 | Warnings | M012 |
| Cough and Chest Congestion DM Adult | DEXTROMETHORPHAN HBR, GUAIFENESIN | CVS Pharmacy | 4444c05a-eba6-4633-b86f-34f455699fa9 | 2026-05-14 | Warnings | M012 |
| Topcare Day Time Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Topco Associates LLC | a88e5b8e-e6dd-4a1c-9628-5861d3205bdb | 2026-05-14 | Warnings | M012 |
| equate daytime cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Wal-Mart Stores Inc | 69b24c67-cf4b-46d7-a44b-d1917cc876b1 | 2026-05-14 | Warnings | M012 |
| GILTUSS DIABETIC EX | GILTUSS DIABETIC EX | Gil Pharmaceutical Corp | ab7915e7-323a-4fe1-887a-a3bd3f0aac98 | 2026-05-13 | Warnings | M012 |
| Giltuss EX Maximum Strength Expectorant | GILTUSS EX MAXIMUM STRENGTH EXPECTORANT | Gil Pharmaceutical Corp | 950db1ca-6936-47f8-a112-e3594d4c922c | 2026-05-13 | Warnings | M012 |
| Giltuss EX Expectorant | GILTUSS EX EXPECTORANT | Gil Pharmaceutical Corp | 3b363fb9-c4d3-446f-927c-f705ffc715b5 | 2026-05-13 | Warnings | M012 |
| Giltuss HBP EX Expectorant | GILTUSS HBP EX EXPECTORANT | Gil Pharmaceutical Corp | 31bd6356-27cf-4188-8fd5-9cd9392021ca | 2026-05-13 | Warnings | M012 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1049906 | diphenhydrAMINE HCl 12.5 MG in 5 mL Oral Solution | PSN | 9bddedbb-40a2-47d3-be35-7b6fce4f755d | 7 |
| 1049906 | diphenhydramine hydrochloride 2.5 MG/ML Oral Solution | SCD | 9bddedbb-40a2-47d3-be35-7b6fce4f755d | 7 |
| 1049906 | diphenhydramine HCl 12.5 MG per 5 ML Oral Solution | SY | 9bddedbb-40a2-47d3-be35-7b6fce4f755d | 7 |
| 1049906 | diphenhydramine hydrochloride 25 MG per 10 ML Oral Solution | SY | 9bddedbb-40a2-47d3-be35-7b6fce4f755d | 7 |
| 1049906 | diphenhydramine hydrochloride 50 MG per 20 ML Oral Solution | SY | 9bddedbb-40a2-47d3-be35-7b6fce4f755d | 7 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 63868-370-04 | 63868037004 | 1 BOTTLE in 1 BOX (63868-370-04) / 118 mL in 1 BOTTLE | 1 bottle | 2014-05-30 | 2026-12-28 | No | No | Current |