Acetaminophen and Diphenhydramine HCL
- Product NDC
- 41415-661
- 11-digit product format
- 414150661
- Labeler code
- 41415
- Product ID
- 41415-661_465302f5-b590-5105-e063-6394a90aa9d0
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen and Diphenhydramine HCL
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- PUBLIX SUPERMARKETS, INC
- Application
- M013
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2024-08-02
- Substance
- DIPHENHYDRAMINE; ACETAMINOPHEN
- Active strength
- 25; 500 mg/1; mg/1
- Pharmacologic classes
- Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- 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 and Diphenhydramine HCL
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| DIPHENHYDRAMINE | 25 mg/1 |
| ACETAMINOPHEN | 500 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 8GTS82S83M | Internal UNII lookup |
| 362O9ITL9D | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1092189 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 08f549cf-042a-7bf2-e063-6394a90a83ef | Available on FDA.report |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 41415-661-05 | Acetaminophen and Diphenhydramine HCL | 50 in 1 BOTTLE | TABLET | 50 | 6 | |
| 41415-661-10 | Acetaminophen and Diphenhydramine HCL | 100 in 1 BOTTLE | TABLET | 100 | 6 |
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 |
|---|---|---|---|---|---|---|
| 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 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1092189 | acetaminophen 500 MG / diphenhydrAMINE HCl 25 MG Oral Tablet | PSN | 08f549cf-042a-7bf2-e063-6394a90a83ef | 6 |
| 1092189 | acetaminophen 500 MG / diphenhydramine hydrochloride 25 MG Oral Tablet | SCD | 08f549cf-042a-7bf2-e063-6394a90a83ef | 6 |
| 1092189 | APAP 500 MG / diphenhydramine hydrochloride 25 MG Oral Tablet | SY | 08f549cf-042a-7bf2-e063-6394a90a83ef | 6 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 41415-661-05 | 41415066105 | 50 TABLET in 1 BOTTLE (41415-661-05) | 50 tablet | 2024-08-02 | No | No | Current |
| 41415-661-10 | 41415066110 | 100 TABLET in 1 BOTTLE (41415-661-10) | 100 tablet | 2024-08-02 | No | No | Current |