Acetaminophen
- Product NDC
- 68071-5239
- 11-digit product format
- 680715239
- Labeler code
- 68071
- Product ID
- 68071-5239_2a95afd1-cd26-371c-e063-6294a90a97d4
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Extra Strength Pain Relief
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- NuCare Pharmaceuticals,Inc.
- Application
- M007
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 1989-01-01
- Substance
- ACETAMINOPHEN
- Active strength
- 500 mg/1
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Acetaminophen
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ACETAMINOPHEN | 500 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 362O9ITL9D | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 198440 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| a32f346e-71d0-cc11-e053-2a95a90ae88c | Available on FDA.report |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 68071-5239-9 | 2022-02-07 | C162847 | 48780-1 | d6a99b39-bd7b-a426-e053-dadaa90af4c2 | gc201 |
| 68071-5239-9 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-bd7b-a426-e053-dadaa90af4c2 | gc201 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 68071-5239-3 | Acetaminophen | 30 in 1 BOTTLE | TABLET | 30 | 7 | |
| 68071-5239-5 | Acetaminophen | 45 in 1 BOTTLE | TABLET | 45 | 7 | |
| 68071-5239-9 | Acetaminophen | 90 in 1 BOTTLE | TABLET | 90 | 7 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 68071-5239 | ACETAMINOPHEN (EXTRA STRENGTH PAIN RELIEF) TABLET [NUCARE PHARMACEUTICALS,INC.] | 7 | Current NDC, Legacy NDC, 3 package rows | 20250101_a32f346e-71d0-cc11-e053-2a95a90ae88c.zip |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| MILK OF MAGNESIA | MAGNESIUM HYDROXIDE | Wal-Mart Stores, Inc. | 750e0355-369e-b679-e053-2a91aa0a66ca | 2023-11-01 | Warnings | M007 |
| MILK OF MAGNESIA | MAGNESIUM HYDROXIDE | Wal-Mart Stores, Inc. | 750efd58-5845-fbc4-e053-2a91aa0a86d1 | 2023-11-01 | Warnings | M007 |
| Gentle Laxative | MAGNESIUM HYDROXIDE | WALGREEN COMPANY | ba4a29b3-2ddc-b906-e053-2995a90a2ab7 | 2023-11-01 | Warnings | M007 |
| DOCUZEN | SENNOSIDES 8.6MG AND DOCUSATE SODIUM 50MG | Proficient Rx LP | 92879e62-f60a-4ab4-9532-610cdd2628ee | 2023-11-01 | Warnings | M007 |
| Docusate Sodium | DOCUSATE SODIUM | A-S Medication Solutions | 5999904a-6ac8-4d9e-951c-6e64e8cd93eb | 2023-11-01 | Warnings | M007 |
| MILK OF MAGNESIA | MAGNESIUM HYDROXIDE | VALU MERCHANDISERS COMPANY | 5e98f9d9-679c-63a2-e053-2991aa0a4b8d | 2023-10-31 | Warnings | M007 |
| MILK OF MAGNESIA | MAGNESIUM HYDROXIDE | VALU MERCHANDISERS COMPANY | 5e957b01-4f44-0a2a-e053-2991aa0a37a0 | 2023-10-31 | Warnings | M007 |
| MILK OF MAGNESIA | MAGNESIUM HYDROXIDE | VALU MERCHANDISERS COMPANY | 5e993b13-8dc8-6653-e053-2a91aa0a4c2a | 2023-10-31 | Warnings | M007 |
| MILK OF MAGNESIA | MAGNESIUM HYDROXIDE | CVS | 3c8e4144-6702-2678-e054-00144ff88e88 | 2023-10-31 | Warnings | M007 |
| Fiber Laxative | CALCIUM POLYCARBOPHIL | Magno-Humphries, Inc. | 9d22c208-d089-8b6a-e053-2995a90ab90a | 2023-10-27 | Warnings | M007 |
| Stool Softener Docusate Sodium | DOCUSATE SODIUM | Magno-Humphries, Inc. | a0e6ab9b-fd31-45fd-93d5-b51d705c180a | 2023-10-27 | Warnings | M007 |
| Sennosides Natural Laxative | SENNOSIDES | Magno-Humphries, Inc. | 9d22bedb-9fca-8421-e053-2a95a90acf4a | 2023-10-27 | Warnings | M007 |
| Stool Softener Docusate Sodium | DOCUSATE SODIUM | Magno-Humphries, Inc. | 9d22d642-8aed-d17e-e053-2995a90ae182 | 2023-10-27 | Warnings | M007 |
| Senna S | DOCUSATE SODIUM, SENNOSIDES | Magno-Humphries, Inc. | 9deaf264-6af0-40ba-e053-2a95a90ada0e | 2023-10-27 | Warnings | M007 |
| FLEET | MINERAL OIL | C.B. Fleet Company, Inc. | 2528cb5e-437e-41f0-9c34-e9ce57404d8b | 2023-10-26 | Warnings | M007 |
| Magnesium Citrate | MAJOR MAGNESIUM CITRATE ORAL SOLUTION - LEMON | Major Pharmaceuticals | 088e5543-c947-af78-e063-6294a90a8bc4 | 2023-10-25 | Warnings | M007 |
| DOK | DOCUSATE SODIUM | MAJOR PHARMACEUTICALS | 7a92070d-98cc-662f-e053-2991aa0aa1b2 | 2023-10-23 | Warnings | M007 |
| Stool Softener | DOCUSATE SODIUM | KROGER COMPANY | a1afaa71-7e8c-5a49-e053-2a95a90a4db0 | 2023-10-23 | Warnings | M007 |
| Stool Softener | DOCUSATE SODIUM | Geri-Care Pharmaceutical Corp | 644d81ec-d38f-4172-a087-727b94e2fefe | 2023-10-19 | Warnings | M007 |
| Docusate Sodium | DOCUSATE SODIUM | Asclemed USA, Inc. | 30fc8c07-c26b-4bcc-a727-6e193f5727fd | 2023-10-16 | Warnings | M007 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 198440 | acetaminophen 500 MG Oral Tablet | PSN | a32f346e-71d0-cc11-e053-2a95a90ae88c | 7 |
| 198440 | acetaminophen 500 MG Oral Tablet | SCD | a32f346e-71d0-cc11-e053-2a95a90ae88c | 7 |
| 198440 | APAP 500 MG Oral Tablet | SY | a32f346e-71d0-cc11-e053-2a95a90ae88c | 7 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 68071-5239-3 | 68071523903 | 30 TABLET in 1 BOTTLE (68071-5239-3) | 30 tablet | 2020-04-13 | No | No | Current | |
| 68071-5239-5 | 68071523905 | 45 TABLET in 1 BOTTLE (68071-5239-5) | 45 tablet | 2020-04-13 | 0000-00-00 | No | No | Current |
| 68071-5239-9 | 68071523909 | 90 TABLET in 1 BOTTLE (68071-5239-9) | 90 tablet | 2020-04-13 | 0000-00-00 | No | No | Current |