Acetaminophen PM
- Product NDC
- 57344-095
- 11-digit product format
- 573440095
- Labeler code
- 57344
- Product ID
- 57344-095_284d3315-9077-e45f-e063-6394a90af0c4
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen and Diphenhydramine Hydrochloride
- Dosage form
- TABLET, COATED
- Route
- ORAL
- Labeler
- AAA Pharmaceutical, Inc.
- Application
- M013
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2012-10-01
- 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
- 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#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 57344-095-01 | Acetaminophen PM | 24 in 1 BOTTLE, PLASTIC | TABLET, COATED | 24 | | 5 |
| 57344-095-01 | Acetaminophen PM | 1 in 1 CARTON | TABLET, COATED | 1 | | 5 |
| 57344-095-02 | Acetaminophen PM | 50 in 1 BOTTLE, PLASTIC | TABLET, COATED | 50 | | 5 |
| 57344-095-02 | Acetaminophen PM | 1 in 1 CARTON | TABLET, COATED | 1 | | 5 |
| 57344-095-03 | Acetaminophen PM | 1 in 1 CARTON | TABLET, COATED | 1 | | 5 |
| 57344-095-03 | Acetaminophen PM | 100 in 1 BOTTLE, PLASTIC | TABLET, COATED | 100 | | 5 |
| 57344-095-12 | Acetaminophen PM | 300 in 1 BOTTLE, PLASTIC | TABLET, COATED | 300 | | 5 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| Acetaminophen | ACTIVE INGREDIENT | 362O9ITL9D | ACETAMINOPHEN PM (ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [AAA PHARMACEUTICAL, INC.] | 1 | |
| DIPHENHYDRAMINE HYDROCHLORIDE | ACTIVE INGREDIENT | TC2D6JAD40 | ACETAMINOPHEN PM (ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [AAA PHARMACEUTICAL, INC.] | 1 | |
| Acetaminophen | ACTIVE MOIETY | 362O9ITL9D | ACETAMINOPHEN PM (ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [AAA PHARMACEUTICAL, INC.] | 1 | |
| DIPHENHYDRAMINE | ACTIVE MOIETY | 8GTS82S83M | ACETAMINOPHEN PM (ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [AAA PHARMACEUTICAL, INC.] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | ACETAMINOPHEN PM (ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [AAA PHARMACEUTICAL, INC.] | 1 | |
| COPOVIDONE K25-31 | INACTIVE INGREDIENT | D9C330MD8B | ACETAMINOPHEN PM (ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [AAA PHARMACEUTICAL, INC.] | 1 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | ACETAMINOPHEN PM (ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [AAA PHARMACEUTICAL, INC.] | 1 | |
| FD&C BLUE NO. 1 | INACTIVE INGREDIENT | H3R47K3TBD | ACETAMINOPHEN PM (ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [AAA PHARMACEUTICAL, INC.] | 1 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | ACETAMINOPHEN PM (ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [AAA PHARMACEUTICAL, INC.] | 1 | |
| LACTOSE | INACTIVE INGREDIENT | J2B2A4N98G | ACETAMINOPHEN PM (ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [AAA PHARMACEUTICAL, INC.] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | ACETAMINOPHEN PM (ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [AAA PHARMACEUTICAL, INC.] | 1 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | ACETAMINOPHEN PM (ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [AAA PHARMACEUTICAL, INC.] | 1 | |
| POVIDONES | INACTIVE INGREDIENT | FZ989GH94E | ACETAMINOPHEN PM (ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [AAA PHARMACEUTICAL, INC.] | 1 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | ACETAMINOPHEN PM (ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [AAA PHARMACEUTICAL, INC.] | 1 | |
| SODIUM STARCH GLYCOLATE TYPE A CORN | INACTIVE INGREDIENT | AG9B65PV6B | ACETAMINOPHEN PM (ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [AAA PHARMACEUTICAL, INC.] | 1 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | ACETAMINOPHEN PM (ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [AAA PHARMACEUTICAL, INC.] | 1 | |
| STEARIC ACID | INACTIVE INGREDIENT | 4ELV7Z65AP | ACETAMINOPHEN PM (ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [AAA PHARMACEUTICAL, INC.] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | ACETAMINOPHEN PM (ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [AAA PHARMACEUTICAL, INC.] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 57344-095 | ACETAMINOPHEN PM (ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [AAA PHARMACEUTICAL, INC.] | 5 | Current NDC, Legacy NDC, 7 package rows | 20241204_409b5fcd-5880-4dda-85d8-26aeceb4f8ab.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 57344-095-01 | 57344009501 | 1 BOTTLE, PLASTIC in 1 CARTON (57344-095-01) / 24 TABLET, COATED in 1 BOTTLE, PLASTIC | 2017-07-01 | 0000-00-00 | No | No | Current |
| 57344-095-02 | 57344009502 | 1 BOTTLE, PLASTIC in 1 CARTON (57344-095-02) / 50 TABLET, COATED in 1 BOTTLE, PLASTIC | 2012-10-01 | 0000-00-00 | No | No | Current |
| 57344-095-03 | 57344009503 | 1 BOTTLE, PLASTIC in 1 CARTON (57344-095-03) / 100 TABLET, COATED in 1 BOTTLE, PLASTIC | 2017-11-01 | 0000-00-00 | No | No | Current |
| 57344-095-12 | 57344009512 | 300 TABLET, COATED in 1 BOTTLE, PLASTIC (57344-095-12) | 2024-03-12 | | No | No | Historical |