Pain and Fever
- Product NDC
- 51316-449
- 11-digit product format
- 513160449
- Labeler code
- 51316
- Product ID
- 51316-449_ce7fbf9f-1ee2-4232-8ad5-3804ba87b9a5
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen
- Dosage form
- TABLET, CHEWABLE
- Route
- ORAL
- Labeler
- CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
- Application
- M013
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2025-12-18
- Substance
- ACETAMINOPHEN
- Active strength
- 160 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
- Pain and Fever
- Brand name suffix
- Childrens
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ACETAMINOPHEN | 160 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 362O9ITL9D | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 313820 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| e55645ab-66f9-4160-8247-395bc5b02711 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| cb89b86a-369e-4204-8910-ae797c503af3 | Product name | 1 | 20230706 |
| d4880ace-a516-8c47-8dfd-73a4ba5887d7 | Product name | 2 | 20180830 |
| 7cda52fc-125f-421c-8fea-bc1974370c49 | Product name | 2 | 20180703 |
| 0ca1d589-929b-4b33-bc5b-1d84abdafa6a | Product name | 1 | 20150324 |
| fc363c46-397b-4476-ac0f-70e43e8e4592 | Product name | 1 | 20150324 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 51316-449-08 | Pain and FeverChildrens | 24 in 1 BOTTLE, PLASTIC | TABLET, CHEWABLE | 24 | 2 | |
| 51316-449-08 | Pain and FeverChildrens | 1 in 1 CARTON | TABLET, CHEWABLE | 1 | 2 |
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 |
|---|---|---|---|---|---|---|
| Sanatos Multi Symptom Daytime | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCI | Pharmadel LLC | 0ab11691-5b29-55fc-e063-6394a90aa328 | 2023-11-17 | Warnings | M013 |
| Acetaminophen | ACETAMINOPHEN | A-S Medication Solutions | 1e223faa-f6d0-4235-bc4c-6cfca84a5b0a | 2023-11-17 | Warnings | M013 |
| SanaTos X | ACETAMINOPHEN, DEXTROMETHORPHAN HBR,GUAIFENESIN, PHENYLEPHRINE HCI | Pharmadel LLC | 85b8ef3d-7318-7f3b-e053-2991aa0a0777 | 2023-11-14 | Warnings | M013 |
| RIGHT REMEDIES EXTRA STRENGTH PM Pain Relief | ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE | Strive Pharmaceuticals Inc. | 8badbaad-eb35-4251-a779-00474819360d | 2023-11-13 | Warnings | M013 |
| Acetaminophen | ACETAMINOPHEN | Trifecta Pharmaceuticals USA LLC | 09935a74-34b0-0e7c-e063-6294a90a7c83 | 2023-11-07 | Warnings | M013 |
| Pain Relief PM | ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE | AMERIFOODS TRADING COMPANY | f6dd6396-93e9-1096-e053-6394a90af06d | 2023-11-02 | Warnings | M013 |
| Acetaminophen | ACETAMINOPHEN | RETAIL BUSINESS SERVICES , LLC. | eb644e9e-36dc-5f84-e053-2a95a90affa5 | 2023-11-02 | Warnings | M013 |
| Good Sense Childrens Pain and Fever | ACETAMINOPHEN | Proficient Rx LP | 46527b1f-7515-44ce-b5cb-9d24223b9af1 | 2023-11-01 | Warnings | M013 |
| Aspirin | ASPIRIN | A-S Medication Solutions | 12feb32b-4b8c-4b17-9e86-cb286457b088 | 2023-11-01 | Warnings | M013 |
| Acetaminophen, Aspirin, Caffeine | ACETAMINOPHEN, ASPIRIN, CAFFEINE | Proficient Rx LP | af8b30a0-7a56-4557-8404-cc8059fcd6bc | 2023-11-01 | Warnings | M013 |
| Acetaminophen | ACETAMINOPHEN | AMERIFOODS TRADING COMPANY | f6dd387d-c768-9443-e053-6394a90aca14 | 2023-10-31 | Warnings | M013 |
| ASPIRIN | ASPIRIN | AMERIFOODS TRADING COMPANY | f6cec280-17a5-5c5d-e053-6394a90a81aa | 2023-10-31 | Warnings | M013 |
| Regular Strength Aspirin | ASPIRIN | CARDINAL HEALTH, INC. | 8aaa82c6-b46b-25c5-e053-2a95a90a3793 | 2023-10-30 | Warnings | M013 |
| SafeTynadol | ACETAMINOPHEN | Sinew Pharma Inc. | b956d527-7ea7-e084-e053-2a95a90a866d | 2023-10-28 | Warnings | M013 |
| Pain Reliever PM | ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE | Magno-Humphries, Inc. | 9d2275c8-0c3d-d2b3-e053-2995a90a368e | 2023-10-27 | Warnings | M013 |
| Pain Reliever | ACETAMINOPHEN | Magno-Humphries, Inc. | 9d22bedb-9fb3-8421-e053-2a95a90acf4a | 2023-10-27 | Warnings | M013 |
| Acetaminophen Regular Strength | ACETAMINOPHEN | Magno-Humphries, Inc. | 9d22d642-8aaf-d17e-e053-2995a90ae182 | 2023-10-27 | Warnings | M013 |
| ENTERIC COATED ASPIRIN | ASPIRIN | Magno-Humphries, Inc. | a7c02378-4213-4e57-aca2-2437ad02f786 | 2023-10-27 | Warnings | M013 |
| Extraprin | ACETAMINOPHEN, ASPIRIN, CAFFEINE | Magno-Humphries, Inc. | 9d22cdc8-29c5-4273-e053-2a95a90ad0bf | 2023-10-27 | Warnings | M013 |
| Regular Strength Enteric coated aspirin | ASPIRIN | Geri-Care Pharmaceutical Corp | c321208c-f192-42c5-9454-e0df5d02d685 | 2023-10-26 | Warnings | M013 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 313820 | acetaminophen 160 MG Chewable Tablet | PSN | e55645ab-66f9-4160-8247-395bc5b02711 | 2 |
| 313820 | acetaminophen 160 MG Chewable Tablet | SCD | e55645ab-66f9-4160-8247-395bc5b02711 | 2 |
| 313820 | APAP 160 MG Chewable Tablet | SY | e55645ab-66f9-4160-8247-395bc5b02711 | 2 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|
| 51316-449-08 | 51316044908 | 1 BOTTLE, PLASTIC in 1 CARTON (51316-449-08) / 24 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC | 2025-12-18 | No | No | Current |