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 |
|---|---|---|---|---|---|---|
| Aspirin | ASPIRIN | Proficient Rx LP | 9c186289-e309-45e8-8934-1d0eae0375c2 | 2024-12-01 | Warnings | M013 |
| Childrens Chewable Acetaminophen | ACETAMINOPHEN | GERI-CARE PHARMACEUTICAL CORP | 22f63d62-c941-5b8f-e063-6394a90aeecd | 2024-11-28 | Warnings | M013 |
| Extra Strength Acetaminophen | ACETAMINOPHEN | Geri-Care Pharmaceutical Corp | 7a7b6318-b7d6-31b1-e053-2991aa0abf25 | 2024-11-28 | Warnings | M013 |
| Extra Strength Pain Reliever PM | ACETAMINOPHEN, DIPHENHYDRAMINE HCL | INGLES MARKETS, INC. | 27fd288e-c07a-617f-e063-6394a90a17a4 | 2024-11-28 | Warnings | M013 |
| BAYER Aspirin Original, TRAVEL BASIX | ASPIRIN | Lil' Drug Store Products, Inc. | 7f5d9ebe-8119-49a2-9380-eca18a5e5e85 | 2024-11-27 | Warnings | M013 |
| EXCEDRIN MIGRAINE | ACETAMINOPHEN, ASPIRIN (NSAID) AND CAFFEINE | Jones Healthcare Group - Packaging Services, Inc | c4168e4d-3dfc-4e51-a32e-14704cb59c66 | 2024-11-27 | Warnings | M013 |
| TYLENOL Extra Strength / TYLENOL Precise Cooling Pain Relief | ACETAMINOPHEN, LIDOCAINE, MENTHOL | Kenvue Brands LLC | 2611e984-0dd5-bda1-e063-6394a90a559a | 2024-11-26 | Warnings | M013 |
| First Aid Only Extra-Strength Non-Aspirin | ACETAMINOPHEN | Acme United Corporation | 6891d57a-10a6-53de-e053-2a91aa0ac7c2 | 2024-11-26 | Warnings | M013 |
| Chewable Aspirin | ASPIRIN | MARC GLASSMAN, INC. | c8314910-71ff-5a55-e053-2995a90aafc7 | 2024-11-26 | Warnings | M013 |
| Aspirin | ASPIRIN | Marc Glassman, Inc. | 7990ca49-fb30-40fe-9ac4-48e89eac9bb2 | 2024-11-26 | Warnings | M013 |
| Enteric Coated Aspirin Regular Strength | ASPIRIN | Safeway | 96359eb6-62bc-4b13-960c-050af99a8c02 | 2024-11-26 | Warnings | M013 |
| ASPIRIN Low Dose | ASPIRIN | Marc Glassman, Inc. | 3d519af3-9398-4439-8253-1e5d4612b8e3 | 2024-11-26 | Warnings | M013 |
| ACETAMINOPHEN (RED) | ACETAMINOPHEN | Humanwell PuraCap Pharmaceutical (Wuhan), Ltd. | 06eabf4b-f8c0-439a-acf1-aa6e3075c717 | 2024-11-25 | Warnings | M013 |
| ACETAMINOPHEN (RED) | ACETAMINOPHEN | Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd | a352f588-4a70-42b2-8f9c-a73a0629517d | 2024-11-25 | Warnings | M013 |
| Pain Relief Extra Strength | ACETAMINOPHEN | Humanwell PuraCap Pharmaceutical (Wuhan), Ltd. | 5c42dd28-820c-4cc5-9016-11ad5e580616 | 2024-11-25 | Warnings | M013 |
| equate pain reliever | ACETAMINOPHEN | WALMART INC. | 4518fe82-3ba8-4e9e-a036-776df7fb8d57 | 2024-11-21 | Warnings | M013 |
| Family Wellness Pain Reliever | ASPIRIN | FAMILY WELLNESS SERVICES, INC. | 075e19f4-1a58-aedd-e063-6294a90af708 | 2024-11-20 | Warnings | M013 |
| Mejoralito | ACETAMINOPHEN | OPMX Chula Vista | fd2ecde0-296e-060f-e053-6294a90afd98 | 2024-11-15 | Warnings | M013 |
| Temp X | ACETAMINOPHEN | OPMX Chula Vista | fd2edc32-0351-c991-e053-6294a90ab4ce | 2024-11-15 | Warnings | M013 |
| CVS Health Extra Strength Antacid and Pain Reliever | ASPIRIN, ANHYDROUS CITRIC ACID, SODIUM BICARBONATE | CVS Pharmacy | afe9e755-18ba-305f-e053-2995a90aa8d0 | 2024-11-14 | 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 |