ACETAMINOPHEN (RED)
- Product NDC
- 53345-010
- 11-digit product format
- 533450010
- Labeler code
- 53345
- Product ID
- 53345-010_27c732b5-1662-f46a-e063-6394a90a9eb4
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- ACETAMINOPHEN
- Dosage form
- CAPSULE, LIQUID FILLED
- Route
- ORAL
- Labeler
- Humanwell PuraCap Pharmaceutical (Wuhan), Ltd.
- Application
- M013
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2013-04-15
- Substance
- ACETAMINOPHEN
- Active strength
- 325 mg/1
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- ACETAMINOPHEN (RED)
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ACETAMINOPHEN | 325 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 362O9ITL9D |
| Rxcui | 198436 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 53345-010-01 | ACETAMINOPHEN (RED) | 5000 in 1 BAG | CAPSULE, LIQUID FILLED | 5000 | | 3 |
| 53345-010-01 | ACETAMINOPHEN (RED) | 1 in 1 BOX | CAPSULE, LIQUID FILLED | 1 | | 3 |
| 53345-010-02 | ACETAMINOPHEN (RED) | 4000 in 1 BAG | CAPSULE, LIQUID FILLED | 4000 | | 3 |
| 53345-010-02 | ACETAMINOPHEN (RED) | 1 in 1 BOX | CAPSULE, LIQUID FILLED | 1 | | 3 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| ACETAMINOPHEN | ACTIVE INGREDIENT | 362O9ITL9D | ACETAMINOPHEN (RED) (ACETAMINOPHEN) CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN), LTD.] | 1 | |
| ACETAMINOPHEN | ACTIVE MOIETY | 362O9ITL9D | ACETAMINOPHEN (RED) (ACETAMINOPHEN) CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN), LTD.] | 1 | |
| FD&C RED NO. 40 | INACTIVE INGREDIENT | WZB9127XOA | ACETAMINOPHEN (RED) (ACETAMINOPHEN) CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN), LTD.] | 1 | |
| FD&C YELLOW NO. 6 | INACTIVE INGREDIENT | H77VEI93A8 | ACETAMINOPHEN (RED) (ACETAMINOPHEN) CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN), LTD.] | 1 | |
| GELATIN | INACTIVE INGREDIENT | 2G86QN327L | ACETAMINOPHEN (RED) (ACETAMINOPHEN) CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN), LTD.] | 1 | |
| GLYCERIN | INACTIVE INGREDIENT | PDC6A3C0OX | ACETAMINOPHEN (RED) (ACETAMINOPHEN) CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN), LTD.] | 1 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | ACETAMINOPHEN (RED) (ACETAMINOPHEN) CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN), LTD.] | 1 | |
| POVIDONE | INACTIVE INGREDIENT | FZ989GH94E | ACETAMINOPHEN (RED) (ACETAMINOPHEN) CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN), LTD.] | 1 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | ACETAMINOPHEN (RED) (ACETAMINOPHEN) CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN), LTD.] | 1 | |
| SORBITOL | INACTIVE INGREDIENT | 506T60A25R | ACETAMINOPHEN (RED) (ACETAMINOPHEN) CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN), LTD.] | 1 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | ACETAMINOPHEN (RED) (ACETAMINOPHEN) CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN), LTD.] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 53345-010 | ACETAMINOPHEN (RED) (ACETAMINOPHEN) CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN) CO., LTD] | 3 | Current NDC, Legacy NDC, 2 package rows | 20241127_a352f588-4a70-42b2-8f9c-a73a0629517d.zip |
| 53345-010 | ACETAMINOPHEN (RED) (ACETAMINOPHEN) CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN), LTD.] | 3 | Current NDC, Legacy NDC, 2 package rows | 20241127_06eabf4b-f8c0-439a-acf1-aa6e3075c717.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 |
|---|
| 53345-010-01 | 53345001001 | 1 BAG in 1 BOX (53345-010-01) / 5000 CAPSULE, LIQUID FILLED in 1 BAG | 1 bag | 2013-04-15 | 0000-00-00 | No | No | Current |
| 53345-010-02 | 53345001002 | 1 BAG in 1 BOX (53345-010-02) / 4000 CAPSULE, LIQUID FILLED in 1 BAG | 1 bag | 2016-04-04 | 0000-00-00 | No | No | Current |