FDA.reportPublic FDA data

FirstCare Childrens Pain Fever Acetaminophen

Product NDC
71594-702
11-digit product format
715940702
Labeler code
71594
Product ID
71594-702_4db0ae88-b364-2877-e063-6394a90a8383
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen 80 mg
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
USpharma Ltd
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-03-23
Substance
ACETAMINOPHEN
Active strength
80 mg/1
NDC exclude flag
No
Listing certified through
2027-12-31
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
FirstCare Childrens Pain Fever Acetaminophen
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN80 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
307696Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
9fc05ba6-5667-457e-82c1-a8b4e16caddaAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
efd58dcf-540a-4531-8766-e713129ca6f2Product name120250307

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71594-702-13FirstCare Childrens Pain Fever Acetaminophen24 in 1 BOTTLE, PLASTICTABLET, CHEWABLE241

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 75 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lil Drug Store Aspirin 325ASPIRINLil Drug Store Products, Incde59aae2-f794-4243-acc8-37a10e27abde2023-12-15WarningsExact identifier
application number: M013
Pain RelieverACETAMINOPHEN TABLET, EXTRA STRENGTHLil' Drug Store Products, Inc.f0fdab5a-9d07-57aa-e053-2a95a90adc7f2023-12-15WarningsExact identifier
application number: M013
BC CherryASPIRIN AND CAFFEINELil' Drug Store Products, Inc79ea721b-d656-44f7-9d13-390debee7be02023-12-15WarningsExact identifier
application number: M013
Alka-SeltzerBUFFERED ASPIRINLil' Drug Store Products, Inc.0c7a60e7-0bde-9aa2-e063-6294a90a32092023-12-14WarningsExact identifier
application number: M013
Circle K Aspirin 325ASPIRINLil Drug Store Products, Inc4cd306e3-2119-4272-9da4-a848fe2746fa2023-12-14WarningsExact identifier
application number: M013
Circle K Pain Reliever Extra StrengthACETAMINOPHENLil' Drug Store Products, Inc.f2359bc3-901f-4ecb-b402-cb2fe404a9352023-12-14WarningsExact identifier
application number: M013
Childrens Pain ReliefACETAMINOPHENDISCOUNT DRUG MARTc55b8f9d-1396-43c0-acc9-5e3485eadb072023-12-08WarningsExact identifier
application number: M013
Childrens Pain ReliefACETAMINOPHENDISCOUNT DRUG MART775519ad-5683-451f-9bfc-5fafc70c68ec2023-12-08WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENWALGREEN CO.c20c814b-35f5-4c46-e053-2a95a90a50f22023-12-08WarningsExact identifier
application number: M013
Acetaminophen Extra StrengthACETAMINOPHENBetter Living Brands LLCf9859be4-6d0b-2ab8-e053-6294a90aa8622023-12-06WarningsExact identifier
application number: M013
Aurophen Regular StrengthACETAMINOPHENKROGER COMPANYb9b7b849-c3b3-9af7-e053-2a95a90a00772023-12-06WarningsExact identifier
application number: M013
Acetaminophen Regular StrengthACETAMINOPHENKROGER COMPANYcf649478-57d2-cc88-e053-2a95a90ad1ba2023-12-06WarningsExact identifier
application number: M013
Acetaminophen Extra StrengthACETAMINOPHENKROGER COMPANYb9b6f878-1ec8-3dc0-e053-2995a90a54142023-12-06WarningsExact identifier
application number: M013
Pain RelieverACETAMINOPHENWALGREEN CO.a48c522c-76c5-49f8-8c4d-3ee6b221e6f32023-12-06WarningsExact identifier
application number: M013
Pain RelieverACETAMINOPHENWALGREEN CO.cc939a7c-ce56-5dd6-e053-2995a90aa8af2023-12-06WarningsExact identifier
application number: M013
Alka-Seltzer Original FlavorBUFFERED ASPIRIN, EFFERVESCENT TABLETLil' Drug Store Products, Inc.ea5df8be-a08c-5fa3-e053-2995a90a0bac2023-12-06WarningsExact identifier
application number: M013
RinglACETAMINOPHENSato Pharmaceutical Co., Ltd.ba5a0286-3e0f-4bef-96e5-29d92f51f4322023-12-06WarningsExact identifier
application number: M013
Pain Relief ChildrensACETAMINOPHENDolgencorp, Inc. (DOLLAR GENERAL & REXALL)41633554-474e-4d3c-9187-d90487d2ae8c2023-12-06WarningsExact identifier
application number: M013
Acetaminophen Extra StrengthACETAMINOPHENFamily Dollar Stores, LLCf86dcbb8-debc-4bce-e053-6294a90a7a022023-12-05WarningsExact identifier
application number: M013
Sanatos Multi Symptom DaytimeACETAMINOPHEN, DEXTROMETHORPHAN HBRPharmadel LLC0a5fc0ef-ba34-bb0b-e063-6394a90af7d92023-12-01WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
307696acetaminophen 80 MG Chewable TabletPSN9fc05ba6-5667-457e-82c1-a8b4e16cadda1
307696acetaminophen 80 MG Chewable TabletSCD9fc05ba6-5667-457e-82c1-a8b4e16cadda1
307696APAP 80 MG Chewable TabletSY9fc05ba6-5667-457e-82c1-a8b4e16cadda1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71594-702-137159407021324 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (71594-702-13) 2026-03-23NoNoCurrent