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 table
IngredientStrength
ACETAMINOPHEN160 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
362O9ITL9DInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
313820Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
e55645ab-66f9-4160-8247-395bc5b02711Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
cb89b86a-369e-4204-8910-ae797c503af3Product name120230706
d4880ace-a516-8c47-8dfd-73a4ba5887d7Product name220180830
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51316-449-08Pain and FeverChildrens24 in 1 BOTTLE, PLASTICTABLET, CHEWABLE242
51316-449-08Pain and FeverChildrens1 in 1 CARTONTABLET, CHEWABLE12

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.

Matched openFDA labels page 62 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
childrens pain reliefACETAMINOPHENPublix Super Markets Incde7dd4dc-c5df-4cac-a83a-b21a7637f3392024-10-02WarningsExact identifier
application number: M013
Good Neighbor Pharmacy childrens pain and feverACETAMINOPHENAmerisource Bergen6ba153b7-9dc9-4e42-9176-13b3922268bd2024-10-02WarningsExact identifier
application number: M013
equaline acetaminophenACETAMINOPHENUnited Natural Foods, Inc. dba UNFId418c676-03c3-4031-bbf4-8bf908d10e4c2024-10-02WarningsExact identifier
application number: M013
childrens fever reducer and pain relieverACETAMINOPHENRite Aid Corporationf6e51c4b-2941-4862-8262-bd97163248412024-10-02WarningsExact identifier
application number: M013
Extra Strength PM Pain MedicineACETAMINOPHEN, DIPHENHYDRAMINE HCLAmerisource Bergen23fbda2b-885b-ce00-e063-6294a90a586e2024-10-01WarningsExact identifier
application number: M013
LOW DOSE ASPIRINASPIRINProficient Rx LPe839bff7-779a-446d-8486-c0e0a1b6d6652024-10-01WarningsExact identifier
application number: M013
Aspirin Low Dose Chewable OrangeASPIRINProficient Rx LP9e08b91c-b067-4ccd-ae0d-01f48f992f202024-10-01WarningsExact identifier
application number: M013
Good Sense Pain ReliefACETAMINOPHENA-S Medication Solutionsd9bebb47-6ff4-4ddc-b48f-18f9423734842024-09-30WarningsExact identifier
application number: M013
basic care acetaminophenACETAMINOPHENAmazon.com Services LLC24fca5f8-1c08-4d1f-8e2c-dc274c4bcd792024-09-29WarningsExact identifier
application number: M013
pain and feverACETAMINOPHENMeijer Distribution Inceef2fef5-34b3-4ac2-94cb-5bd6b4c5ab1c2024-09-27WarningsExact identifier
application number: M013
good sense childrens pain and feverACETAMINOPHENA-S Medication Solutionsce4ae43b-4ec2-42d1-b665-9114aaeb857e2024-09-26WarningsExact identifier
application number: M013
Childrens TYLENOLACETAMINOPHENKenvue Brands LLCd8aa3b1a-5f63-49db-998c-35cd11bd733f2024-09-25WarningsExact identifier
application number: M013
meijer LOW DOSE AspirinASPIRINMeijer, Inc.1bf12831-5d50-c1b4-e063-6394a90a69702024-09-24WarningsExact identifier
application number: M013
Good Sense Pain ReliefACETAMINOPHENL. Perrigo Company7f2038d3-9c95-4d83-b459-49ba8a3cd0ad2024-09-23WarningsExact identifier
application number: M013
pain relief extra strengthACETAMINOPHENPublix Super Markets Incdd01adcd-26a1-416e-92fc-8b6c0cc5512e2024-09-23WarningsExact identifier
application number: M013
Signature Care Pain ReliefACETAMINOPHENSafeway917bcd06-6dc6-42b3-80b4-c6746b3472612024-09-22WarningsExact identifier
application number: M013
equaline childrens acetaminophenACETAMINOPHENUnited Natural Foods, Inc. dba UNFI1e0cbb47-08f6-4afb-ad5a-6ce1b262ab972024-09-19WarningsExact identifier
application number: M013
ASPIRINASPIRINTARGET CORPORATION8ed252be-8fdb-3809-e053-2995a90a4b4f2024-09-19WarningsExact identifier
application number: M013
DoloDent Toothache For adultsACETAMINOPHEN, CAFFEINEPharmadel LLC1e7a0c06-ad3c-b94f-e063-6394a90abab12024-09-19WarningsExact identifier
application number: M013
foster and thrive childrens pain and feverACETAMINOPHENStrategic Sourcing Services LLC0a4b10e3-29df-40a5-a3fa-0e9beeadfbb42024-09-19WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313820acetaminophen 160 MG Chewable TabletPSNe55645ab-66f9-4160-8247-395bc5b027112
313820acetaminophen 160 MG Chewable TabletSCDe55645ab-66f9-4160-8247-395bc5b027112
313820APAP 160 MG Chewable TabletSYe55645ab-66f9-4160-8247-395bc5b027112

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
51316-449-08513160449081 BOTTLE, PLASTIC in 1 CARTON (51316-449-08) / 24 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC2025-12-18NoNoCurrent