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 |
|---|---|---|---|---|---|---|
| AXIV NightTime | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | VIVUNT PHARMA LLC | 131f6314-c9a1-7af3-e063-6294a90abe6f | 2025-09-17 | Warnings | M012 |
| AXIV DayTime - NightTime 48 Softgels | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | VIVUNT PHARMA LLC | 1320e243-344f-98ed-e063-6294a90a0092 | 2025-09-17 | Warnings | M012 |
| AXIV Sinus Severe Mucus | ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HYDROCLORIDE | VIVUNT PHARMA LLC | 13245298-8b78-e177-e063-6294a90a6bec | 2025-09-17 | Warnings | M012 |
| GoodSense Tussin CF Multi-Symptom Cold, Raspberry | DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Geiss, Destin & Dunn Inc. | 3f05cf84-d485-7688-e063-6394a90ae740 | 2025-09-17 | Warnings | M012 |
| Daytime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Family Dollar (FAMILY WELLNESS) | 5d7466b4-fdb7-432b-880d-e7aa4a4acbda | 2025-09-17 | Warnings | M012 |
| allergy relief Childrens | DIPHENHYDRAMINE HCL | United Natural Foods, Inc. dba UNFI | e34d8bf5-e12e-453c-93ea-9c7988c4f13d | 2025-09-16 | Warnings | M012 |
| DayTime Cold Flu Non Drowsy | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE | Harris Teeter, LLC | 67beb9f6-4e0a-4f7b-b50a-4bcd3a01354f | 2025-09-16 | Warnings | M012 |
| DOMETUSS | CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE | Domel Laboratories | 3ebfc62f-27f6-48b2-9bae-bdefbd1d05fe | 2025-09-16 | Warnings | M012 |
| CareOne Severe Congestion Nasal | OXYMETAZOLINE HYDROCHLORIDE | American Sales Company | d1dba68b-c4e1-4afc-9aee-6a51341b89f5 | 2025-09-16 | Warnings | M012 |
| Daytime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | FSA Store Inc. (Caring Mills) | e69ef8dc-09d2-46de-aebf-ba735f4cc7ea | 2025-09-16 | Warnings | M012 |
| Menthol Cough Drops Honey Lemon Flavor | MENTHOL HONEY LEMON FLAVOR | CVS Pharmacy | 3ea9a1f2-75b3-c67a-e063-6294a90a8caf | 2025-09-13 | Warnings | M012 |
| Menthol Cough Drops Honey Lemon Flavor | MENTHOL HONEY LEMON FLAVOR | CVS Pharmacy | 3eab4cf9-6fdc-a6fb-e063-6394a90a8633 | 2025-09-13 | Warnings | M012 |
| COLD AND FLU DAYTIME-NIGHTTIME | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | TARGET CORP | 9de9fab3-890a-158d-e053-2a95a90af423 | 2025-09-13 | Warnings | M012 |
| Diphenhydramine Hydrochloride | DIPHENHYDRAMINE HYDROCHLORIDE | Precision Dose, Inc. | 4d0f4f5b-3135-4457-bb8f-ad9d28ca5ea4 | 2025-09-12 | Warnings | M012 |
| Nasal Spray, Circle K | OXYMETAZOLINE HYDROCHLORIDE 0.05% SOLUTION | Lil' Drug Store Products, Inc. | 3ea06e88-a2c6-621b-e063-6294a90a1075 | 2025-09-12 | Warnings | M012 |
| Daytime Nighttime Cold Flu Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | Harris Teeter, LLC | a0090dc6-0fe5-4ab2-a2cf-6ed19892f363 | 2025-09-12 | Warnings | M012 |
| Multi Symptom Cold and Multi Symptom Nighttime Cold Childrens | DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCI, ACETAMINOPHEN, DIPHENHYDRAMINE HCI, PHENYLEPHRINE HCI | CVS Pharmacy | ebf2dbb4-96fa-4bf6-9afd-8aa8b5369f2e | 2025-09-12 | Warnings | M012 |
| Daytime Nighttime Cold Flu Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | FSA Store Inc. (Caring Mills) | 8d7bb31b-a47d-4252-a0a7-79d286179fb9 | 2025-09-12 | Warnings | M012 |
| Daytime Nighttime Cold Flu Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | Family Dollar (FAMILY WELLNESS) | 150e5c3a-7c86-4b66-af30-a376df697401 | 2025-09-12 | Warnings | M012 |
| SEVERE COUGH COLD AND FLU | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 67f8d405-a2ad-4ade-93b4-9b09a0d81d8e | 2025-09-11 | 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 |