Diphenhydramine HCl
- Product NDC
- 51316-221
- 11-digit product format
- 513160221
- Labeler code
- 51316
- Product ID
- 51316-221_5c9028c4-3131-a0c1-e063-6294a90ad84c
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Diphenhydramine HCl
- Dosage form
- TABLET, COATED
- Route
- ORAL
- Labeler
- CVS Pharmacy, Inc.
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2024-01-31
- Substance
- DIPHENHYDRAMINE HYDROCHLORIDE
- Active strength
- 50 mg/1
- Pharmacologic classes
- Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- 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
- Diphenhydramine HCl
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| DIPHENHYDRAMINE HYDROCHLORIDE | 50 mg/1 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 0e2e0f88-b076-afe1-4bdd-32bca4375bec | Product name | 3 | 20250127 |
| 594e2c86-3079-4e6e-96c9-48f7a8afc78d | Product name | 1 | 20230718 |
| 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 |
|---|---|---|---|---|---|---|
| 51316-221-08 | Diphenhydramine HCl | 2 in 1 CARTON | TABLET, COATED | 2 | 1 | |
| 51316-221-08 | Diphenhydramine HCl | 12 in 1 BLISTER PACK | TABLET, COATED | 12 | 1 |
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 |
|---|---|---|---|---|---|---|
| Chest Rub | CAMPHOR (SYNTHETIC), EUCALYPTUS OIL, AND MENTHOL | Dabur India Limited | 22916978-303d-e62a-e063-6394a90a2100 | 2024-09-20 | Warnings | M012 |
| Topcare Nasal Decongestant Maximum Strength Non Drowsy | PSEUDOEPHEDRINE HCL | Topco Associates LLC | 1a9e0336-c0c2-43f8-aeea-668d4a209714 | 2024-09-20 | Warnings | M012 |
| Leader Nasal Decongestant | PSEUDOEPHEDRINE HCL | Cardinal Health 110, LLC. dba Leader | 25609b66-047c-46e7-bc95-20eb8e6c9617 | 2024-09-20 | Warnings | M012 |
| equaline nasal | PHENYLEPHRINE HYDROCHLORIDE | United Natural Foods, Inc. dba UNFI | 67fdd277-7a7a-4404-8ca2-39802c46405f | 2024-09-20 | Warnings | M012 |
| equaline tussin | DEXTROMETHORPHAN HBR, GUAIFENESIN | United Natural Foods, Inc. dba UNFI | 8bc7fa7c-d565-48c9-9808-1042c3e9d428 | 2024-09-20 | Warnings | M012 |
| Leader Adult Tussin Mucus and Chest Congestion 541 | GUAIFENESIN | CARDINAL HEALTH 110, LLC. DBA LEADER | d7fae410-9c1c-4231-9fde-2c51ad3d7e95 | 2024-09-20 | Warnings | M012 |
| sinus | PSEUDOEPHEDRINE HYDROCHLORIDE | Kroger Company | 18812f2a-9b66-45a7-9631-123da6fd1c1f | 2024-09-20 | Warnings | M012 |
| Good Sense Nasal Four | PHENYLEPHRINE HYDROCHLORIDE | L. Perrigo Company | 930469c1-384c-4440-b3e6-9dcd674871c4 | 2024-09-19 | Warnings | M012 |
| Cold and Flu Relief Multi Symptom Nighttime | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | WinCo Foods, LLC | 89272d2d-5533-4ae8-865b-cb204cec6d65 | 2024-09-17 | Warnings | M012 |
| Cold and Flu Relief Multi Symptom Nighttime | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | WinCo Foods, LLC | 5791c1c7-f614-4940-a45a-6291742e1e22 | 2024-09-17 | Warnings | M012 |
| nasal decongestant | OXYMETAZOLINE HYDROCHLORIDE | Safeway | 2affd44d-2125-4a1f-919c-c082e7644ea8 | 2024-09-17 | Warnings | M012 |
| DAYTIME COLD AND FLU RELIEF SOFTGELS NON-DROWSY | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE | Advanced Rx LLC | fa1a4d86-87bb-0c50-e053-6394a90a56e2 | 2024-09-13 | Warnings | M012 |
| NIGHTTIME COLD AND FLU RELIEF SOFTGELS MULTI-SYMPTOM | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | Advanced Rx LLC | fa1b60b1-49cb-1211-e053-6394a90a0a46 | 2024-09-13 | Warnings | M012 |
| nasal | PHENYLEPHRINE HYDROCHLORIDE | Walgreen Company | 8db7df1c-46b5-49bd-9002-50b12d58001a | 2024-09-13 | Warnings | M012 |
| meijer Daytime Cold and Flu SOFTGEL | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE | Meijer, Inc. | 1bdd7f8a-93ce-5309-e063-6294a90a91f0 | 2024-09-12 | Warnings | M012 |
| oxymetazoline hcl | OXYMETAZOLINE HYDROCHLORIDE | Padagis Israel Pharmaceuticals Ltd | a1103cd8-344b-4a65-8a60-3c7be86d01a6 | 2024-09-11 | Warnings | M012 |
| Good Sense Nasal | OXYMETAZOLINE HYDROCHLORIDE | L. Perrigo Company | 276d7d3c-c4a7-4754-8845-c38f85aac5f7 | 2024-09-08 | Warnings | M012 |
| foster and thrive nasal | OXYMETAZOLINE HYDROCHLORIDE | Strategic Sourcing Services LLC | 4ff5a4ae-9649-4a6d-a5f8-ca23efbbb479 | 2024-09-08 | Warnings | M012 |
| equate nasal original | OXYMETAZOLINE HYDROCHLORIDE | Wal-Mart Stores Inc | 7e40c9b8-e0b5-448a-a674-72388fbab189 | 2024-09-08 | Warnings | M012 |
| Anefrin Nasal Original | OXYMETAZOLINE HYDROCHLORIDE | Walgreen Company | 85b442dc-1703-4fef-948a-fad7cbe9f224 | 2024-09-07 | Warnings | M012 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1085945 | diphenhydrAMINE HCl 50 MG Oral Tablet | PSN | 1059b55b-c218-843f-e063-6294a90af2fe | 1 |
| 1085945 | diphenhydramine hydrochloride 50 MG Oral Tablet | SCD | 1059b55b-c218-843f-e063-6294a90af2fe | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 51316-221-08 | 51316022108 | 2 BLISTER PACK in 1 CARTON (51316-221-08) / 12 TABLET, COATED in 1 BLISTER PACK | 2 blister pack | 2024-01-31 | 2028-11-30 | No | No | Historical |