Acetaminophen and Diphenhydramine citrate
- Product NDC
- 57631-010
- 11-digit product format
- 576310010
- Labeler code
- 57631
- Product ID
- 57631-010_403a87a6-fe92-8e79-e063-6394a90a70ce
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen and Diphenhydramine citrate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- InvaTech Pharma Solutions LLC
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2025-10-01
- Substance
- ACETAMINOPHEN; DIPHENHYDRAMINE CITRATE
- Active strength
- 500; 38 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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Acetaminophen and Diphenhydramine citrate
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ACETAMINOPHEN | 500 mg/1 |
| DIPHENHYDRAMINE CITRATE | 38 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 362O9ITL9D, 4OD433S209 |
| Rxcui | 1099872 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 57631-010-00 | Acetaminophen and Diphenhydramine citrate | 30000 in 1 BOX | TABLET | 30000 | | 4 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 57631-010-00 | 57631001000 | 30000 TABLET in 1 BOX (57631-010-00) | 30000 tablet | 2025-10-01 | No | No | Current |