Kids Pain and Fever

Product NDC
69676-0041
11-digit product format
696760041
Labeler code
69676
Product ID
69676-0041_51597a5f-8ed4-7534-e063-6394a90a859a
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
LIQUID
Route
ORAL
Labeler
Genexa Inc.
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-09-13
Substance
ACETAMINOPHEN
Active strength
160 mg/5mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 9 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage69676-0041-3302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage69676-0041-9302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage69676-0041-3ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage69676-0041-9ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage69676-0041-30efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage69676-0041-90efc9e666f02…f202fb6c5f17…

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
Kids Pain and Fever
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN160 mg/5mL

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
307668Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
a7bd0b92-6f85-6175-e053-2995a90ab837Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
69676-0041-32025-02-21Kids' Pain & Fever
69676-0041-92025-02-21Kids' Pain & Fever
69676-0041-32025-01-30Kids' Pain & Fever
69676-0041-92025-01-30Kids' Pain & Fever

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69676-0041-3Kids Pain and Fever5 mL in 1 POUCHLIQUID512
69676-0041-9Kids Pain and Fever118 mL in 1 BOTTLE, PLASTICLIQUID11812
69676-0041-9Kids Pain and Fever1 in 1 CARTONLIQUID112

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69676-0041KIDS PAIN AND FEVER (ACETAMINOPHEN) LIQUID [GENEXA INC.]11Current NDC, Legacy NDC, 3 package rows20250523_a7bd0b92-6f85-6175-e053-2995a90ab837.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.

Matched openFDA labels page 71 of 79 · 1,576 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Excedrin Extra Strength Pain RelieverACETAMINOPHEN, ASPIRIN (NSAID), AND CAFFEINEHaleon US Holdings LLC0faa3592-4d56-4645-9a0e-066e0bdfebb62024-04-05WarningsExact identifier
application number: M013
Pain Relief Childrens Dye FreeACETAMINOPHENH E B3f9beeeb-5e27-4b81-a647-20e65f0e9fc92024-04-03WarningsExact identifier
application number: M013
Low Dose AspirinASPIRINH E Bedb321dd-e5cb-4031-a8a8-efce9e86fe162024-04-03WarningsExact identifier
application number: M013
Childrens Pain ReliefACETAMINOPHENH E Ba0c0277e-50aa-4328-8f93-ab20c6176b2b2024-04-03WarningsExact identifier
application number: M013
Regular Strength Enteric coated aspirinASPIRINBryant Ranch Prepackbda805ab-7f37-405d-a144-4e06ad9a29a12024-04-03WarningsExact identifier
application number: M013
Headache Relief Extra StrengthACETAMINOPHEN, ASPIRIN, CAFFEINEFamily Dollar (FAMILY WELLNESS)650cb15e-c448-4df3-b0f8-4398be05d8412024-03-27WarningsExact identifier
application number: M013
Good Sense Effervescent Pain ReliefASPIRINPerrigo Direct, Inc.103027a7-2f0e-8d8c-e063-6294a90aedc72024-03-26WarningsExact identifier
application number: M013
rugby infants acetaminophenACETAMINOPHENRugby Laboratories8aa9ac68-ca61-4163-a876-52034138c1ea2024-03-25WarningsExact identifier
application number: M013
Equate Pain Reliever Acetaminophen for Adults 250 mgACETAMINOPHENWalmart Inc08a18481-f029-f01f-e063-6294a90aac652024-03-21WarningsExact identifier
application number: M013
Equate Pain Reliever Acetaminophen for Adults 250 mgACETAMINOPHENWalmart Inc0d106fa2-2a77-deb2-e063-6394a90a2dac2024-03-21WarningsExact identifier
application number: M013
Pain Relief Extra StrengthACETAMINOPHENEQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)872c5220-a379-4dc1-b99c-f11ebb82db352024-03-19WarningsExact identifier
application number: M013
Pain Reliever PM Extra StrengthACETAMINOPHEN, DIPHENHYDRAMINE HCLEQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)79886972-47a4-44c5-a131-1a691a3281032024-03-19WarningsExact identifier
application number: M013
Headache Relief Extra StrengthACETAMINOPHEN, ASPIRIN, CAFFEINEDolgencorp, Inc. (DOLLAR GENERAL & REXALL)5ffcc78d-9163-4cb4-8811-ae9f0142806a2024-03-18WarningsExact identifier
application number: M013
ASPIRIN LOW DOSE CHEWABLE ORANGE PAIN RELIEVERASPIRIN LOW DOSE CHEWABLE ORANGE PAIN RELIEVERHF Acquisition Co LLC, DBA HealthFirst13e621dc-b2b4-98fd-e063-6394a90acc752024-03-17WarningsExact identifier
application number: M013
Childrens Pain and FeverACETAMINOPHENCVS PHARMACY, INC097a9c98-a092-400d-9600-6797b0b9a50c2024-03-15WarningsExact identifier
application number: M013
Excedrin PM Triple Action Caplets and Excedrin Tension HeadacheACETAMINOPHEN, ASPIRIN (NSAID), CAFFEINE, AND DIPHENHYDRAMINE CITRATEHaleon US Holdings LLC978a9d27-6d41-42cb-a193-11314923d2ac2024-03-14WarningsExact identifier
application number: M013
Excedrin PM Triple Action CapletsACETAMINOPHEN, ASPIRIN (NSAID) AND DIPHENHYDRAMINE CITRATEHaleon US Holdings LLCb3812d27-40af-40d7-864a-dfa4ae34cb9e2024-03-14WarningsExact identifier
application number: M013
Excedrin Extra Strength Pain RelieverACETAMINOPHEN, ASPIRIN (NSAID), AND CAFFEINEHaleon US Holdings LLC691b754c-bafc-47e2-a322-cf56245c01f62024-03-14WarningsExact identifier
application number: M013
Childrens Pain and FeverACETAMINOPHENCVS PHARMACY, INCfdc80b2a-d7c1-4b3d-9a9b-28182c6320de2024-03-14WarningsExact identifier
application number: M013
Pain ReliefACETAMINOPHENQUALITY CHOICE (Chain Drug Marketing Association)2cde052d-22a4-470f-8d6a-7c17061b8ac82024-03-14WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
307668acetaminophen 160 MG in 5 mL Oral SuspensionPSNa7bd0b92-6f85-6175-e053-2995a90ab83712
307668acetaminophen 32 MG/ML Oral SuspensionSCDa7bd0b92-6f85-6175-e053-2995a90ab83712
307668acetaminophen 160 MG per 5 ML Oral SuspensionSYa7bd0b92-6f85-6175-e053-2995a90ab83712
307668acetaminophen 320 MG per 10 ML Oral SuspensionSYa7bd0b92-6f85-6175-e053-2995a90ab83712
307668acetaminophen 650 MG per 20.3 ML Oral SuspensionSYa7bd0b92-6f85-6175-e053-2995a90ab83712
307668acetaminophen 80 MG per 2.5 ML Oral SuspensionSYa7bd0b92-6f85-6175-e053-2995a90ab83712
307668APAP 32 MG/ML Oral SuspensionSYa7bd0b92-6f85-6175-e053-2995a90ab83712

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69676-0041-3696760041035 mL in 1 POUCH (69676-0041-3) 5 ml2023-09-130000-00-00YesNoCurrent
69676-0041-9696760041091 BOTTLE, PLASTIC in 1 CARTON (69676-0041-9) / 118 mL in 1 BOTTLE, PLASTIC2025-03-060000-00-00NoNoCurrent