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 |
|---|---|---|---|---|---|---|
| Childrens Acetaminophen | ACETAMINOPHEN | Major Pharmaceuticals | 38b839b6-de7d-4f33-a19a-efc92cdad92c | 2025-01-24 | Warnings | M013 |
| good sense pain relief | ACETAMINOPHEN | Preferred Pharmaceuticals Inc. | 523b68da-cd2a-4960-95e7-de5d51ce33c1 | 2025-01-23 | Warnings | M013 |
| Safety Coated Aspirin 81 mg Low Dose | ASPIRIN 81MG | Ulai Health LLC | 3d225a11-a53b-4dc2-9c25-13cab007900f | 2025-01-20 | Warnings | M013 |
| Pharbetol | ACETAMINOPHEN 325 MG | Ulai Health LLC | 55bb7e6c-e98c-48bd-b7bb-9848ff0273ca | 2025-01-20 | Warnings | M013 |
| ACETAMINOPHEN PM | ACETAMINOPHEN 500MG / DIPHENHYDRAMINE HCL 25MG | Ulai Health LLC | d4a568c9-a721-48d1-aebc-fc65444947ce | 2025-01-20 | Warnings | M013 |
| Pharbetol | ACETAMINOPHEN 500MG | Ulai Health LLC | c9d3cee1-531c-439f-ae19-07acd366aad6 | 2025-01-20 | Warnings | M013 |
| Percogesic Original Strength | ACETAMINOPHEN AND DIPHENHYDRAMINE HCL | Medtech Products Inc. | 529974c2-0121-4892-8e47-c2c447581091 | 2025-01-17 | Warnings | M013 |
| Little Remedies Childrens Fever Pain Reliever | ACETAMINOPHEN | Medtech Products Inc. | e1e44c85-d10c-4997-8f85-064cda7906eb | 2025-01-17 | Warnings | M013 |
| Stanback | ASPIRIN AND CAFFEINE | Medtech Products Inc. | caaa1313-09e4-45aa-8836-346f6a370196 | 2025-01-17 | Warnings | M013 |
| Dye Free Childrens Acetaminophen | ACETAMINOPHEN | Precision Dose Inc. | 5cc698fa-0841-4851-ae21-0aac8b40eb0a | 2025-01-16 | Warnings | M013 |
| Ecotrin | ASPIRIN | Medtech Products Inc. | 222d187b-aae6-410b-baeb-b2bd42f5c676 | 2025-01-16 | Warnings | M013 |
| Children Pain and Fever Reliever | ACETAMINOPHEN | Target Corporation | 0dd643a4-3cbc-423d-95b4-ba373b09d895 | 2025-01-16 | Warnings | M013 |
| Chewable Low Dose Aspirin | ASPIRIN | TARGET CORPORATION | f934e72a-2e9f-da17-e053-6394a90a1a2e | 2025-01-15 | Warnings | M013 |
| ACETAMINOPHEN 500 MG | ACETAMINOPHEN | Reliable 1 Laboratories LLC | 2651bf11-4d66-43ba-e054-00144ff88e88 | 2025-01-15 | Warnings | M013 |
| ASPIRIN 325 MG EC | ASPIRIN | Reliable 1 Laboratories LLC | 2ab8564f-f958-7512-e054-00144ff88e88 | 2025-01-15 | Warnings | M013 |
| ACETAMINOPHEN 325 MG | ACETAMINOPHEN | Reliable 1 Laboratories LLC | 25626b46-78f8-7226-e054-00144ff8d46c | 2025-01-15 | Warnings | M013 |
| Aspirin 81 mg | ASPIRIN | Reliable 1 Laboratories LLC | b247fe39-7f65-e502-e053-2a95a90a08f1 | 2025-01-15 | Warnings | M013 |
| Pharbetol | ACETAMINOPHEN 500MG | Ulai Health LLC | e64ce7b1-4501-4b51-b012-1882ed153b42 | 2025-01-13 | Warnings | M013 |
| Aspirin Regular Strength | ASPIRIN 325MG | Ulai Health LLC | 26942d32-d6e6-464d-8fc4-ffd9806d3e62 | 2025-01-12 | Warnings | M013 |
| ACETAMINOPHEN | ACETAMINOPHEN | WAL-MART STORES INC | a354b24e-0913-829f-e053-2995a90ad407 | 2025-01-11 | 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 |