CounterAct
- Product NDC
- 54473-304
- 11-digit product format
- 544730304
- Labeler code
- 54473
- Product ID
- 54473-304_7fbf2b51-9097-0a1f-e053-2991aa0a6aa1
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen and Diphenhydramine
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Melaleuca, Inc.
- Application
- part343
- Marketing category
- OTC MONOGRAPH NOT FINAL
- Marketing start
- 2016-05-02
- 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
- CounterAct
- Brand name suffix
- 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#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 54473-304-01 | CounterActPM | 1 in 1 BOX | TABLET | 1 | | 2 |
| 54473-304-50 | CounterActPM | 50 in 1 BOTTLE | TABLET | 50 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 54473-304 | COUNTERACT PM (ACETAMINOPHEN AND DIPHENHYDRAMINE) TABLET [MELALEUCA, INC.] | 2 | Current NDC, Legacy NDC, 2 package rows | 20190119_7f9a0062-0e86-1deb-e053-2a91aa0a9188.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 54473-304-01 | 54473030401 | 1 BOTTLE in 1 BOX (54473-304-01) / 50 TABLET in 1 BOTTLE (54473-304-50) | 1 bottle | 2016-05-02 | 0000-00-00 | No | No | Current |
| 54473-304-50 | 54473030450 | 50 in 1 BOTTLE | | | | | | Historical |