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 27 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Acetaminophen Diphenhydramine HCLACETAMINOPHEN DIPHENHYDRAMINE HCLWALGREENS CO.d92d97a8-0ee3-1206-e053-2a95a90a72a82025-12-19WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENSAM'S WEST INC0c8e7095-0806-4501-e063-6394a90a89aa2025-12-19WarningsExact identifier
application number: M013
Acetaminophen Diphenhydramine HCLACETAMINOPHEN DIPHENHYDRAMINE HCLWALGREEN CO.b3763182-2428-155a-e053-2995a90ab5782025-12-19WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENWALGREENSe467b78e-9f23-5563-e053-2a95a90a586e2025-12-19WarningsExact identifier
application number: M013
Acetaminophen Diphenhydramine HCLACETAMINOPHEN DIPHENHYDRAMINE HCLWalgreensfd7c3250-35d4-494a-e053-6394a90a2db52025-12-19WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENCVS PHARMACY, INC1ddb8a2b-3081-3eda-e063-6294a90ab82b2025-12-19WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENCVS PHARMACY, INCb1307d52-10e6-46e1-e053-2995a90a03b62025-12-19WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENCVS PHARMACY, INCc2c6d6a1-b492-506d-e053-2995a90aac232025-12-19WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENFAMILY DOLLARf8383108-0970-9f1e-e053-6294a90ad38f2025-12-19WarningsExact identifier
application number: M013
ACETAMINOPHEN 500 MGACETAMINOPHENNUVICARE LLC591ee107-e953-4982-b75f-13a0afd7c4ae2025-12-19WarningsExact identifier
application number: M013
Nuvicare Headache ReliefACETAMINOPHEN, ASPIRIN, CAFFEINENUVICARE LLC3ede0fb6-c089-4253-9878-2b01c39e9c872025-12-19WarningsExact identifier
application number: M013
Aspirin Low DoseASPIRINNUVICARE LLC3a4aa3c7-b726-4303-8803-74196fa5637a2025-12-19WarningsExact identifier
application number: M013
ACETAMINOPHEN 500 MGACETAMINOPHENNUVICARE LLC95edf7bd-b6a7-4be5-9ad7-8748e7c2d06e2025-12-19WarningsExact identifier
application number: M013
Pain Relief PMACETAMINOPHEN, DIPHENHYDRAMINENUVICARE LLC32a5611b-9bf6-4850-a7ff-fa240da04f452025-12-19WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENBETTER LIVING BRANDS LLC.ac0e96d0-746e-fb42-e053-2a95a90a19572025-12-18WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENBETTER LIVING BRANDS LLC.ac0e5dc0-96eb-47b2-e053-2995a90add0e2025-12-18WarningsExact identifier
application number: M013
Acetaminophen Diphenhydramine HClACETAMINOPHEN DIPHENHYDRAMINE HCLBETTER LIVING BRANDS LLC.ac0f8d5c-d200-1156-e053-2a95a90aece62025-12-18WarningsExact identifier
application number: M013
Pain and Fever ChildrensACETAMINOPHENCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDe55645ab-66f9-4160-8247-395bc5b027112025-12-18WarningsExact identifier
application number: M013
Dolex ForteACETAMINOPHEN, ASPIRIN, CAFFEINEPharmadel LLC3c2d90fc-130d-476c-e063-6294a90a8c152025-12-17WarningsExact identifier
application number: M013
CareOne Childrens AcetaminophenACETAMINOPHENAmerican Sales Company07bc6632-fabb-427d-81f3-c27c54caa6a02025-12-17WarningsExact 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