Acetaminophen Diphenhydramine HCL
- Product NDC
- 75907-431
- Requested package NDC
- 75907-431-01
- 11-digit product format
- 759070431
- Labeler code
- 75907
- Product ID
- 75907-431_d948fa6f-21f3-1861-6421-e5642bf8e4d3
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen Diphenhydramine HCL
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Dr. Reddy's Laboratories Inc.
- Application
- M013
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2026-09-25
- Substance
- ACETAMINOPHEN; DIPHENHYDRAMINE
- Active strength
- 500; 25 mg/1; 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
- Acetaminophen Diphenhydramine HCL
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ACETAMINOPHEN | 500 mg/1 |
| DIPHENHYDRAMINE | 25 mg/1 |
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 |
|---|---|---|---|---|---|---|
| Enteric Coated Aspirin | ASPIRIN | STRATEGIC SOURCING SERVICES LLC | 32cc6e05-84c1-4710-bebc-cb6e7133dc54 | 2024-10-17 | Warnings | M013 |
| Aspirin | ASPIRIN | STRATEGIC SOURCING SERVICES LLC | 2ca87a29-1f54-4da4-a66f-3b3dd4f0396c | 2024-10-17 | Warnings | M013 |
| Pain Relief Extra Strength | ACETAMINOPHEN | STRATEGIC SOURCING SERVICES LLC | 9f0aef5d-20b0-469d-a58d-1cbf83a0dd8e | 2024-10-17 | Warnings | M013 |
| Aspirin | ASPIRIN | Kroger Company | 453f62d5-f580-4d19-bfae-4f78c2a6b6d6 | 2024-10-16 | Warnings | M013 |
| Acetaminophen Extra Strength | ACETAMINOPHEN | FSA Store Inc. | ec6add55-f4a3-7818-e053-2a95a90aee04 | 2024-10-16 | Warnings | M013 |
| ASPIRIN | ASPIRIN | FSA Store Inc. | 062e7b7b-d052-82b0-e063-6294a90a7cce | 2024-10-16 | Warnings | M013 |
| Acetaminophen PM | ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE | FSA STORE INC. | f4322f34-ac19-371e-e053-2a95a90ac864 | 2024-10-16 | Warnings | M013 |
| Low dose Chewable Aspirin | ASPIRIN | FSA STORE INC. | f939b44c-93b6-ca61-e053-6394a90ae586 | 2024-10-16 | Warnings | M013 |
| Pain Relief | ACETAMINOPHEN | DISCOUNT DRUG MART | 850b5ad8-8774-413c-ae38-022215a94f95 | 2024-10-16 | Warnings | M013 |
| LOW DOSE ASPIRIN | ASPIRIN | DISCOUNT DRUG MART | af0f50d2-3e2d-f723-e053-2995a90a0d4b | 2024-10-16 | Warnings | M013 |
| Enteric Coated Aspirin | ASPIRIN | DISCOUNT DRUG MART | 03ed19dd-1cfc-47d5-b83e-ffa2ebe93f48 | 2024-10-16 | Warnings | M013 |
| PAIN RELIEF Regular Strength | ACETAMINOPHEN | AMERICAN SALES COMPANY | 2e3eabc8-193b-4397-a43c-db838eb16e67 | 2024-10-15 | Warnings | M013 |
| Chewable Aspirin | ASPIRIN | RETAIL BUSINESS SERVICES , LLC. | c94d68ea-7f25-881f-e053-2995a90aa47f | 2024-10-15 | Warnings | M013 |
| LOW DOSE ASPIRIN | ASPIRIN | RETAIL BUSINESS SERVICES , LLC. | c94d750e-5a85-77f5-e053-2995a90a6915 | 2024-10-15 | Warnings | M013 |
| Infants Pain and Fever | ACETAMINOPHEN | Walgreen Company | 9e08eb38-7538-4fa0-a0e1-047ab6cb1680 | 2024-10-15 | Warnings | M013 |
| pain relief | ACETAMINOPHEN | PUBLIX SUPER MARKETS INC | 9e779cc6-4641-6132-e053-2a95a90a3493 | 2024-10-11 | Warnings | M013 |
| Pain Reliever | ACETAMINOPHEN | CHAIN DRUG CONSORTIUM | 5c1a3081-ae25-4895-bf76-ebcbb9fc8072 | 2024-10-11 | Warnings | M013 |
| Aspirin 81 MG | ASPIRIN | Meijer | b3e5711c-9529-4eec-871d-de8efa858b86 | 2024-10-11 | Warnings | M013 |
| Acetaminophen | ACETAMINOPHEN | MEIJER DISTRIBUTION INC | 9586e830-a285-4a07-8b34-969875442348 | 2024-10-11 | Warnings | M013 |
| Pain Relief Extra Strength | ACETAMINOPHEN | Chain Drug Marketing Association | 68a52858-35c5-402a-8ceb-8d8a7c1e5f6c | 2024-10-11 | Warnings | M013 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 75907-431-01 | 75907043101 | 1 BOTTLE in 1 CARTON (75907-431-01) / 100 TABLET in 1 BOTTLE | 1 bottle | 2026-09-25 | No | No | Current |