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 |
|---|---|---|---|---|---|---|
| Daytime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE | Best Choice (Valu Merchandisers Company) | bfec14d5-d9ce-4b9c-a803-3d01cb00b56c | 2026-06-22 | Warnings | M012 |
| Cold and Flu Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE | WinCo Foods, LLC | 5f1aaa8e-c65f-43b3-9850-c60c1663d78f | 2026-06-22 | Warnings | M012 |
| DAY TIME INTENSE FLU | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE | Meijer, Inc. | e5a64d5a-c1ff-453d-b0c1-fe265b9e2c8a | 2026-06-22 | Warnings | M012 |
| NO DRIP NASAL | PHENYLEPHRINE HYDROCHLORIDE | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 7a866cdf-1c0c-403a-afc8-0e99e0ce81aa | 2026-06-22 | Warnings | M012 |
| Maximum Strength Multi-Symptom Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HBR | KROGER COMPANY | 30d4c4b9-0f5f-0279-e063-6394a90af1b5 | 2026-06-19 | Warnings | M012 |
| GoodMeds Nasal Decongestant | PHENYLEPHRINE HYDROCHLORIDE | Cabinet Health P.B.C. | 6a8a961c-d2d2-428d-8af7-8527aae25c8a | 2026-06-19 | Warnings | M012 |
| equaline nighttime cold and flu relief | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | United Natural Foods, Inc. dba UNFI | 490766e7-1781-4b2b-a8f4-d4efb9fff560 | 2026-06-19 | Warnings | M012 |
| Equate Nasal | PHENYLEPHRINE HYDROCHLORIDE | WALMART INC. | 30f6d588-ad80-4348-a45f-77337e067bca | 2026-06-19 | Warnings | M012 |
| GUAIFENESIN | GUAIFENESIN | Cardinal Health 107, LLC | 888b6a2e-6631-4585-a7fe-eb122eb51b23 | 2026-06-18 | Warnings | M012 |
| Extra Strength TYLENOL Cold plus Flu Multi Symptom Day | ACETAMINOPHEN AND DEXTROMETHORPHAN HYDROBROMIDE | Kenvue Brands LLC | 5487b2e1-b0e5-0236-e063-6394a90a3a8b | 2026-06-18 | Warnings | M012 |
| Vaporizing Colds Rub | MENTHOL | Delon Laboratories (1990) Ltd | 3ed8bc0c-c229-450b-a491-06b578c1b8ee | 2026-06-18 | Warnings | M012 |
| Allergy Childrens | DIPHENHYDRAMINE HCL | DOLGENCORP, LLC | 218c447e-9ddd-428a-9b33-0acec35e0d1b | 2026-06-17 | Warnings | M012 |
| Childrens Allergy Relief | DIPHENHYDRAMINE HCL | WALMART INC. | a9d5f9f4-ddec-4ad6-ad06-4a612008bb68 | 2026-06-17 | Warnings | M012 |
| Childrens Allergy Relief | DIPHENHYDRAMINE HCL | Walgreen Company | e49d2a0f-6588-439b-8a46-c073e0bc4f9a | 2026-06-17 | Warnings | M012 |
| COLD AND FLU RELIEF | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | Safeway | ac0380ad-c9fa-4bda-ab84-c2e6aa672bdf | 2026-06-17 | Warnings | M012 |
| daytime severe cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Amazon.com Services LLC | 1a21cbb2-1ba5-414f-a31f-42b7a7bddae5 | 2026-06-16 | Warnings | M012 |
| Tussin DM Regular | DEXTROMETHORPHAN HBR AND GUAIFENESIN | AARNA USA, Inc. | 5460c809-71c8-3ad6-e063-6294a90a4e4f | 2026-06-16 | Warnings | M012 |
| Equate Severe Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE | WALMART INC. | 4b111580-cd20-43ec-9ff4-4b9f74f7d2e8 | 2026-06-16 | Warnings | M012 |
| Sinus Congestion | PHENYLEPHRINE HCL | Chain Drug Marketing Association, Inc. | 43a77f89-e66a-4db6-8067-f614c0e207df | 2026-06-16 | Warnings | M012 |
| severe sinus congestion relief Maximum Strength | ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL | Rite Aid Corporation | 51175d3e-e1c3-4e4d-ad32-61600e87568c | 2026-06-16 | 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 |