FDA.reportPublic FDA data

Family Wellness Childrens Pain Reliever 574

Product NDC
55319-930
11-digit product format
553190930
Labeler code
55319
Product ID
55319-930_fbee12d5-9f0d-40b4-9d3f-3b397960143d
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
SUSPENSION
Route
ORAL
Labeler
Family Dollar Services, Inc.
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-04-18
Substance
ACETAMINOPHEN
Active strength
160 mg/5mL
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
Family Wellness Childrens Pain Reliever 574
Listing expiration
2026-12-31

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
902c1136-04d2-41f0-81c6-412663cdf378Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55319-930-03Family Wellness Childrens Pain Reliever 5741 in 1 CARTONSUSPENSION12
55319-930-03Family Wellness Childrens Pain Reliever 574118 mL in 1 BOTTLESUSPENSION1182

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55319-930FAMILY WELLNESS CHILDRENS PAIN RELIEVER 574 (ACETAMINOPHEN) SUSPENSION [FAMILY DOLLAR SERVICES, INC.]1Current NDC, 2 package rows20240420_902c1136-04d2-41f0-81c6-412663cdf378.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 72 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
Excedrin Tension HeadacheACETAMINOPHEN, CAFFEINEHaleon US Holdings LLC12c074d1-81ac-47d2-8747-b018cda0058a2024-03-13WarningsExact identifier
application number: M013
Menstrual CompleteACETAMINOPHEN, CAFFEINE, PYRILAMINE MALEATEStrive Pharmaceuticals Inc.78c12459-3b27-4ed0-943d-520794eb438d2024-03-07WarningsExact identifier
application number: M013
Pain Reliever fever Reducer Extra StrengthACETAMINOPHENCVS Pharmacy7b5263ad-01b7-4fc5-9384-4da8efe89e352024-03-06WarningsExact identifier
application number: M013
Excedrin Extra Strength GeltabsACETAMINOPHEN, ASPRIN, CAFFEINEHaleon US Holdings LLC11a8439b-0159-4351-b0f5-fe7fad6a33c02024-03-05WarningsExact identifier
application number: M013
Winco Foods Effervescent Pain ReliefASPIRINWinco Foods, LLC128afdd7-a9d1-8957-e063-6294a90af5692024-03-05WarningsExact identifier
application number: M013
Aspirin Low Dose Safety CoatedASPIRINCare One (Retail Business Services, LLC.)6659e103-fa03-4de0-af42-d2fbd548a87c2024-03-05WarningsExact identifier
application number: M013
Dolex Children Pain and FeverACETAMINOPHENPharmadel LLCf9158463-aeb1-5de0-e053-6294a90a748b2024-03-04WarningsExact identifier
application number: M013
SEDALMEX FORTEACETAMINOPHEN, ASPIRIN, CAFFEINEBelmora LLC33b3508e-4caa-4d05-9b15-cb82a2ee2d4d2024-02-28WarningsExact identifier
application number: M013
Pain ReliefACETAMINOPHENAMERISOURCE BERGEN2b923a97-836c-4dac-a8c0-3047a35fb62e2024-02-23WarningsExact identifier
application number: M013
Pain Reliever PM Extra StrengthACETAMINOPHEN, DIPHENHYDRAMINE HCLBJWC (Berkley & Jensen / BJ's)b20a08f3-c9c0-4bd9-8ce0-acb932b5bb862024-02-22WarningsExact identifier
application number: M013
M-PAPACETAMINOPHENBryant Ranch Prepack31a41976-7f65-42d7-acf5-de9c2c5ca58e2024-02-20WarningsExact identifier
application number: M013
Publix Fast Relief Effervescent - Original FlavorASPIRINPUBLIX SUPER MARKETS INC.0a342f72-45fd-3e12-e063-6394a90ae33e2024-02-16WarningsExact identifier
application number: M013
Equaline Effervescent Pain RelieverASPIRINUNITED NATURAL FOODS, INC. DBA UNFI0761299a-e913-7665-e063-6394a90a60032024-02-16WarningsExact identifier
application number: M013
TopCare Effervescent Pain ReliefASPIRINTOPCO ASSOCIATES LLC075f36e1-110c-e839-e063-6294a90a89d72024-02-16WarningsExact identifier
application number: M013
Extra Strength Pain RelieverACETAMINOPHENINGLES MARKETS, INC.115d0b4f-6f0f-79a9-e063-6394a90ab18a2024-02-14WarningsExact identifier
application number: M013
PANADOLACETAMINOPHENHaleon US Holdings LLCe1799765-c247-42b4-ad6a-8ba7d136abf22024-02-06WarningsExact identifier
application number: M013
Panadol Cold and Flu NonDrowsyACETAMINOPHEN AND PHENYLEPRINE HCLHaleon US Holdings LLCf626ab17-01c9-4493-ba9e-0c8c111463842024-02-06WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
307668acetaminophen 160 MG in 5 mL Oral SuspensionPSN902c1136-04d2-41f0-81c6-412663cdf3782
307668acetaminophen 32 MG/ML Oral SuspensionSCD902c1136-04d2-41f0-81c6-412663cdf3782
307668acetaminophen 160 MG per 5 ML Oral SuspensionSY902c1136-04d2-41f0-81c6-412663cdf3782
307668acetaminophen 320 MG per 10 ML Oral SuspensionSY902c1136-04d2-41f0-81c6-412663cdf3782
307668acetaminophen 650 MG per 20.3 ML Oral SuspensionSY902c1136-04d2-41f0-81c6-412663cdf3782
307668acetaminophen 80 MG per 2.5 ML Oral SuspensionSY902c1136-04d2-41f0-81c6-412663cdf3782
307668APAP 32 MG/ML Oral SuspensionSY902c1136-04d2-41f0-81c6-412663cdf3782

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
55319-930-03553190930031 BOTTLE in 1 CARTON (55319-930-03) / 118 mL in 1 BOTTLE1 bottle2024-04-18NoNoCurrent