Diphenhydramine Hydrochloride
- Product NDC
- 71679-308
- 11-digit product format
- 716790308
- Labeler code
- 71679
- Product ID
- 71679-308_5535aeab-2fdb-8e48-e063-6294a90ab610
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Diphenhydramine Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Health Pharma USA LLC
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2026-06-27
- Substance
- DIPHENHYDRAMINE HYDROCHLORIDE
- Active strength
- 25 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 Hydrochloride
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| DIPHENHYDRAMINE HYDROCHLORIDE | 25 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| TC2D6JAD40 | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1049630 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 31755678-825c-b84a-e063-6294a90a5a83 | Available on FDA.report |
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 |
|---|---|---|---|---|---|---|
| Cold and Flu Relief Nighttime | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | Safeway, Inc. | d6ac0d70-0511-4ec8-bb35-8b2e0e3d7742 | 2024-05-15 | Warnings | M012 |
| Night Time Cough | DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | Safeway, Inc. | f658a03b-6fc2-4b63-b3ab-7e886fbf20b4 | 2024-05-15 | Warnings | M012 |
| AXIV DM Max | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | VIVUNT PHARMA LLC | 18704e66-ee8f-315d-e063-6294a90a5282 | 2024-05-14 | Warnings | M012 |
| Menthol Cough Drops | MENTHOL | Target Corporation Inc. | 187622dc-ecde-181d-e063-6294a90a4e8f | 2024-05-14 | Warnings | M012 |
| Lemon Mint Drops | MENTHOL | Target Corporation Inc. | 1876df19-398a-23d8-e063-6394a90ae7e8 | 2024-05-14 | Warnings | M012 |
| Cold Flu and Sore Throat Relief Maximum Strength | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Safeway, Inc. | 6c952c81-c8b6-4e74-abd8-781f6f44736b | 2024-05-14 | Warnings | M012 |
| Pain and Sinus Reliever | ACETAMINOPHEN AND PHENYLEPHRINE | JHK DBA American Safety & First Aid | 249373c6-f56f-4bd3-9cef-98b7ee73457d | 2024-05-14 | Warnings | M012 |
| Nasal | PHENYLEPHRINE HYDROCHLORIDE | Meijer, Inc. | fea71cb9-e044-4729-ad26-1db0cdb9dd11 | 2024-05-14 | Warnings | M012 |
| Nighttime Cold and Flu Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | Safeway, Inc. | a70ead03-6d2c-44c1-9ae5-f6c4094821ec | 2024-05-14 | Warnings | M012 |
| Day Time Cold and Flu Relief non drowsy | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE | Safeway, Inc. | cc450f89-a156-48e0-82ae-19782f13c2ca | 2024-05-13 | Warnings | M012 |
| Daytime Nighttime Cold Flu Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | Safeway, Inc. | a8df5c04-0f92-4013-b3e5-2b45009a7b8d | 2024-05-13 | Warnings | M012 |
| Daytime Nighttime Cold and Flu | ACETAMINOPHEN DEXTROMETHORPHAN HBR PHENYLEPHRINE HCI DOXYLAMINESUCINATE | Safeway, Inc. | f762600a-f4b1-4869-a04b-8431c3d8a3e3 | 2024-05-13 | Warnings | M012 |
| Cold and Flu DayTime | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE | Safeway, Inc. | ef0cd436-5e81-47a7-92d6-58495283ab28 | 2024-05-13 | Warnings | M012 |
| Tussin Cough Sugar Free | DEXTROMETHORPHAN HBR GUAIFENESIN | P & L Development, LLC | 7ed2fe86-3346-4308-a9b6-6a264f879b02 | 2024-05-09 | Warnings | M012 |
| Severe Cold and Flu Daytime | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | KROGER COMPANY | 10106c90-f2f0-508e-e063-6294a90a544b | 2024-05-08 | Warnings | M012 |
| Nighttime Cold and Flu | ACETAMINOPHEN, DEXTROMETHROPHAN HBR, DOXYLAMINE SUCCINATE | Kroger | 1013ce02-7b12-335e-e063-6394a90af3e6 | 2024-05-08 | Warnings | M012 |
| Nighttime Cold and Flu | ACETAMINOPHEN, DEXTROMETHROPHAN HBR, DOXYLAMINE SUCCINATE | Kroger | 10b08ea8-693e-eb18-e063-6394a90af548 | 2024-05-08 | Warnings | M012 |
| Nighttime Severe Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | Kroger | 10b0bcff-d3bc-f70c-e063-6394a90a35ed | 2024-05-08 | Warnings | M012 |
| Daytime Severe Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Kroger | 10b0e0a0-b878-0a9a-e063-6394a90a20e0 | 2024-05-08 | Warnings | M012 |
| Severe Cold and Flu Daytime Honey | ACETAMINOPHEN, DEXTROMETHROPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Kroger | 10b0fa3d-d6b2-272a-e063-6394a90a1205 | 2024-05-08 | Warnings | M012 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|
| 71679-308-00 | 71679030800 | 100000 TABLET, FILM COATED in 1 BOTTLE (71679-308-00) | 2026-06-27 | No | No | Current |