Childrens Pain Relief

Product NDC
37808-482
11-digit product format
378080482
Labeler code
37808
Product ID
37808-482_b4de4354-f780-4447-b679-19bc4a5c067f
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
SUSPENSION
Route
ORAL
Labeler
H E B
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2015-03-08
Substance
ACETAMINOPHEN
Active strength
160 mg/5mL
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
Childrens Pain Relief
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
a0c0277e-50aa-4328-8f93-ab20c6176b2bAvailable on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
37808-482-042023-02-15C16284748780-1f386c649-e78d-0266-e053-dadaa90a7c1aDrug Facts
37808-482-042023-01-30C16284748780-1f386c649-e78d-0266-e053-dadaa90a7c1aDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
37808-482-04Childrens Pain Relief118 mL in 1 BOTTLE, PLASTICSUSPENSION1187
37808-482-04Childrens Pain Relief1 in 1 BOXSUSPENSION17

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
37808-482CHILDRENS PAIN RELIEF (ACETAMINOPHEN) SUSPENSION [H E B]7Current NDC, Legacy NDC, 2 package rows20240404_a0c0277e-50aa-4328-8f93-ab20c6176b2b.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 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
307668acetaminophen 160 MG in 5 mL Oral SuspensionPSNa0c0277e-50aa-4328-8f93-ab20c6176b2b7
307668acetaminophen 32 MG/ML Oral SuspensionSCDa0c0277e-50aa-4328-8f93-ab20c6176b2b7
307668acetaminophen 160 MG per 5 ML Oral SuspensionSYa0c0277e-50aa-4328-8f93-ab20c6176b2b7
307668acetaminophen 320 MG per 10 ML Oral SuspensionSYa0c0277e-50aa-4328-8f93-ab20c6176b2b7
307668acetaminophen 650 MG per 20.3 ML Oral SuspensionSYa0c0277e-50aa-4328-8f93-ab20c6176b2b7
307668acetaminophen 80 MG per 2.5 ML Oral SuspensionSYa0c0277e-50aa-4328-8f93-ab20c6176b2b7
307668APAP 32 MG/ML Oral SuspensionSYa0c0277e-50aa-4328-8f93-ab20c6176b2b7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
37808-482-04378080482041 BOTTLE, PLASTIC in 1 BOX (37808-482-04) / 118 mL in 1 BOTTLE, PLASTIC2015-03-080000-00-00NoNoCurrent