Benadryl
- Product NDC
- 85237-1960
- 11-digit product format
- 852371960
- Labeler code
- 85237
- Product ID
- 85237-1960_55d102a9-ee25-98b4-e063-6294a90a90dc
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Diphenhydramine Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Select Consumer Group
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2008-09-01
- 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
- Benadryl
- 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#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 55d10292-e673-9896-e063-6294a90a5674 | 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 |
|---|---|---|---|---|---|---|
| good neighbor pharmacy adult tussin DM | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | Amerisource Bergen | ced71993-f535-4e28-bc1d-3fcb7d86e9b7 | 2024-11-08 | Warnings | M012 |
| adult tussin dm | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | CVS Pharmacy | 2f1dc8f8-79c5-4724-99aa-a55330ed9d5f | 2024-11-08 | Warnings | M012 |
| good sense day time cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | L. Perrigo Company | 4ac6b64a-8214-4b03-8aa5-0d3199cf0b72 | 2024-11-08 | Warnings | M012 |
| tussin | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | H E B | 1dd9afb6-9b58-4274-a557-900a0cb23524 | 2024-11-08 | Warnings | M012 |
| DG health sinus severe | OXYMETAZOLINE HYDROCHLORIDE | Dolgencorp, LLC | 7abaa912-be8b-463c-8818-104e79b33539 | 2024-11-07 | Warnings | M012 |
| Extra Strength TYLENOL Cold Plus Flu Multi-Action Day | ACETAMINOPHEN, PSEUDOEPHEDRINE HYDROCHLORIDE, AND DEXTROMETHORPHAN HYDROBROMIDE | Kenvue Brands LLC | 7d3266dc-879a-4d28-b8ea-74d238c3020a | 2024-11-07 | Warnings | M012 |
| TYLENOL COLD PLUS FLU SEVERE DAY/NIGHT | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Kenvue Brands LLC | 2ddb86a8-e34c-4a03-a60a-d3fedaf90608 | 2024-11-07 | Warnings | M012 |
| Tylenol Cold Plus Head Congestion Severe | ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Kenvue Brands LLC | ce43e5c2-fe96-4462-882c-d7479318b33d | 2024-11-07 | Warnings | M012 |
| TYLENOL SINUS PLUS HEADACHE DAY | ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE | Kenvue Brands LLC | e608d214-cc46-4a24-ac85-1040e36e7403 | 2024-11-07 | Warnings | M012 |
| Childrens TYLENOL COLD PLUS COUGH PLUS SORE THROAT | ACETAMINOPHEN AND DEXTROMETHORPHAN HYDROBROMIDE | Kenvue Brands LLC | e83f7911-22b4-4ffc-8f49-68f6acd2ebf5 | 2024-11-07 | Warnings | M012 |
| Extra Strength TYLENOL Severe Cough Plus Sore Throat Night | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE AND DOXYLAMINE SUCCINATE. | Kenvue Brands LLC | f81d924e-10e9-0e9d-e053-6294a90a2ddf | 2024-11-07 | Warnings | M012 |
| Childrens TYLENOL COLD Plus FLU | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE | Kenvue Brands LLC | 8b516736-86ac-47cb-a0ec-038d4c3a0020 | 2024-11-07 | Warnings | M012 |
| Tylenol Cold plus Flu plus Cough Night | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, AND PHENYLEPHRINE HYDROCHLORIDE | Kenvue Brands LLC | e85e5eb9-3ecf-4784-999e-111e38e306f5 | 2024-11-07 | Warnings | M012 |
| TYLENOL COLD PLUS FLU SEVERE | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Kenvue Brands LLC | ef8a846d-4b29-4fd8-a683-fada04d0a2b9 | 2024-11-07 | Warnings | M012 |
| Childrens TYLENOL COLD Plus FLU | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE | Kenvue Brands LLC | 9761c807-75a1-4498-a8c6-1f2b1c9ffde6 | 2024-11-07 | Warnings | M012 |
| TYLENOL Cold Plus Mucus Severe | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Kenvue Brands LLC | 24ac94e8-b223-424e-bcd2-9c027c8ff9ed | 2024-11-07 | Warnings | M012 |
| Primatene | EPHEDRINE HYDROCHLORIDE | Foundation Consumer Brands | 2170f081-c03f-47e8-bc63-4052c5e653fa | 2024-11-07 | Warnings | M012 |
| Rompe Pecho Max Multi Symptoms | ACETAMINOPHEN, DEXTROMETHOPHAN HBR, PHENYLEPHRINE HCL, GUAIFENESIN | EFFICIENT LABORATORIES INC | 938e4e47-d2d9-4b0d-bf88-e9f41b501945 | 2024-11-07 | Warnings | M012 |
| topcare sinus nasal | OXYMETAZOLINE HYDROCHLORIDE | Topco Associates LLC | ca1fefed-e9d7-430a-9da4-972b1a6fb786 | 2024-11-07 | Warnings | M012 |
| Leader Daytime Severe Cold and Flu Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Cardinal Health 110, LLC. dba Leader | dd82a389-9ec5-4b3f-a9ea-1a56871ebd17 | 2024-11-07 | Warnings | M012 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 85237-1960-1 | 85237196001 | 1 POUCH in 1 BLISTER PACK (85237-1960-1) / 2 TABLET, FILM COATED in 1 POUCH (85237-1960-0) | 1 pouch | 2012-06-04 | No | No | Current |
| 85237-1960-2 | 85237196002 | 2 POUCH in 1 BLISTER PACK (85237-1960-2) / 2 TABLET, FILM COATED in 1 POUCH (85237-1960-0) | 2 pouch | 2012-06-04 | No | No | Current |
| 85237-1960-3 | 85237196003 | 20 POUCH in 1 CARTON (85237-1960-3) / 2 TABLET, FILM COATED in 1 POUCH (85237-1960-0) | 20 pouch | 2012-06-04 | No | No | Current |
| 85237-1960-4 | 85237196004 | 25 POUCH in 1 CARTON (85237-1960-4) / 2 TABLET, FILM COATED in 1 POUCH (85237-1960-0) | 25 pouch | 2012-06-04 | No | No | Current |
| 85237-1960-5 | 85237196005 | 30 POUCH in 1 CARTON (85237-1960-5) / 2 TABLET, FILM COATED in 1 POUCH (85237-1960-0) | 30 pouch | 2012-06-04 | No | No | Current |
| 85237-1960-7 | 85237196007 | 3 POUCH in 1 BLISTER PACK (85237-1960-7) / 2 TABLET, FILM COATED in 1 POUCH (85237-1960-0) | 3 pouch | 2025-06-04 | No | No | Current |