Extra strength Acetaminophen PM
- Product NDC
- 49483-430
- 11-digit product format
- 494830430
- Labeler code
- 49483
- Product ID
- 49483-430_3a6f8b16-c8a2-7195-e063-6394a90ac5fd
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen 500mg/ Diphenhydramine HCl 25mg
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- TIME CAP LABS INC
- Application
- M013
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2023-07-22
- Substance
- ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE
- 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
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Extra strength Acetaminophen PM
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ACETAMINOPHEN | 500 mg/1 |
| DIPHENHYDRAMINE HYDROCHLORIDE | 25 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 362O9ITL9D, TC2D6JAD40 |
| Rxcui | 1092189 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 49483-430-40 | Extra strength Acetaminophen PM | 400 in 1 BOTTLE | TABLET | 400 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 49483-430 | EXTRA STRENGTH ACETAMINOPHEN PM (ACETAMINOPHEN 500MG/ DIPHENHYDRAMINE HCL 25MG) TABLET [TIME CAP LABS INC] | 2 | Current NDC, 1 package rows | 20250212_010c5c98-fc67-a9c3-e063-6394a90aa640.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 49483-430-40 | 49483043040 | 400 TABLET in 1 BOTTLE (49483-430-40) | 400 tablet | 2023-07-22 | No | No | Current |