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 |
|---|---|---|---|---|---|---|
| topcare infants pain and fever | ACETAMINOPHEN | Topco Associates LLC | a1145ac3-3e55-4bd5-a53e-6cf869add9a1 | 2024-07-02 | Warnings | M013 |
| Drug Mart Effervescent Pain Relief | ASPIRIN | Discount Drug Mart Inc | 1c35f394-a221-6531-e063-6394a90acb8a | 2024-07-01 | Warnings | M013 |
| Aspirin | ASPIRIN | Wildman Business Group | cdbfcf14-8685-40a9-9778-a3b4329dc1ad | 2024-07-01 | Warnings | M013 |
| Back Pain Relief Extra Strength Doans | MAGNESIUM SALICYLATE | Wildman Business Group | 2e17664f-a83f-48d1-8b2b-37f41eea65b6 | 2024-07-01 | Warnings | M013 |
| Meijer Effervescent Pain Relief | ASPIRIN | Meijer Distribution Inc | 17553911-e0fc-e355-e063-6394a90af7b8 | 2024-06-28 | Warnings | M013 |
| leader childrens pain and fever | ACETAMINOPHEN | Cardinal Health 110, LLC. dba Leader | 4fb4f4b2-c238-4933-b874-08def3b34a28 | 2024-06-26 | Warnings | M013 |
| good neighbor pharmacy pain and fever childrens | ACETAMINOPHEN | Amerisource Bergen | ca0833ef-837b-47dc-8676-e016af96622c | 2024-06-26 | Warnings | M013 |
| leader childrens pain and fever | ACETAMINOPHEN | Cardinal Health 110, LLC. dba Leader | 4a030c3e-8104-4a0a-98c5-6ab469451f20 | 2024-06-26 | Warnings | M013 |
| Childrens Acetaminophen | ACETAMINOPHEN | Padagis Israel Pharmaceuticals Ltd | a426dd82-b2d6-405e-b0af-cfb1310a6e19 | 2024-06-26 | Warnings | M013 |
| Pain Reliever | ACETAMINOPHEN | WALMART INC. (see also Equate) | 7d86a03f-74f4-4b24-b6a6-8747acfe905e | 2024-06-26 | Warnings | M013 |
| leader childrens pain and fever | ACETAMINOPHEN | Cardinal Health 110, LLC. dba Leader | 5bcc5da9-7e64-4308-a5be-2f47a8ca774d | 2024-06-25 | Warnings | M013 |
| Codeine-Guaifenesin | CODEINE PHOSPHATE AND GUAIFENESIN | NuCare Pharmaceuticals,Inc. | 9e691264-d48a-6b48-e053-2995a90a9352 | 2024-06-20 | Warnings | M013 |
| Aspirin | REGULAR STRENGTH ENTERIC COATED ASPIRIN | NuCare Pharmceuticals,Inc. | a0705f4f-55cb-214a-e053-2995a90aa680 | 2024-06-20 | Warnings | M013 |
| Extra Strength Pain Reliever | ACETAMINOPHEN 500 MG | Lil' Drug Store Products, Inc. | ee8e0e79-4da4-101f-e053-2a95a90a30a4 | 2024-06-19 | Warnings | M013 |
| Extra Strength Headache Relief | ACETAMINOPHEN, ASPIRIN, AND CAFFEINE | Lil' Drug Store Products, Inc. | b3a06e4b-0b31-4e2a-8dd1-9de85760477b | 2024-06-19 | Warnings | M013 |
| pain relief | ACETAMINOPHEN | Meijer Distribution Inc | 43c3fe72-a4ef-48a6-bc22-a644919c0c5c | 2024-06-17 | Warnings | M013 |
| Aspirin Regular Strength | ASPIRIN | RETAIL BUSINESS SERVICES , LLC. | 093182a6-3ed8-5a3f-e063-6294a90a354a | 2024-06-14 | Warnings | M013 |
| ACETAMINOPHEN PM | ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE | RETAIL BUSINESS SERVICES , LLC. | 093199be-e92a-6f60-e063-6294a90a8533 | 2024-06-14 | Warnings | M013 |
| Acetaminophen | ACETAMINOPHEN | RETAIL BUSINESS SERVICES , LLC. | 09315a3d-bb2d-4f06-e063-6294a90a3bd3 | 2024-06-14 | Warnings | M013 |
| Pain Relief Regular Strength | ACETAMINOPHEN | CHAIN DRUG MARKETING ASSOCIATION INC | 613bc633-0426-41a7-aea9-9ff56311b607 | 2024-06-13 | 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 |