FDA.reportPublic FDA data

Childrens Pain Reliever

Product NDC
37808-499
11-digit product format
378080499
Labeler code
37808
Product ID
37808-499_dfaaf62c-a43d-41c4-806e-41ff1430d26d
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
H E B
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-02-09
Substance
ACETAMINOPHEN
Active strength
160 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
Childrens Pain Reliever
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN160 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
313820Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
c713556c-cb9e-4ed2-bc2f-49b3d6256c0fAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
cb89b86a-369e-4204-8910-ae797c503af3Product name120230706
d4880ace-a516-8c47-8dfd-73a4ba5887d7Product name220180830
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
37808-499-08Childrens Pain Reliever6 in 1 BLISTER PACKTABLET, CHEWABLE67
37808-499-08Childrens Pain Reliever4 in 1 CARTONTABLET, CHEWABLE47

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
37808-499CHILDRENS PAIN RELIEVER (ACETAMINOPHEN) TABLET, CHEWABLE [H E B]6Current NDC, Legacy NDC, 2 package rows20250427_c713556c-cb9e-4ed2-bc2f-49b3d6256c0f.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 76 of 79 · 1,576 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Acetaminophen Extra StrengthACETAMINOPHENAurohealth LLC03d42892-4465-4089-90a7-cd5f00c356022023-11-29WarningsExact identifier
application number: M013
Acetaminophen Extra StrengthACETAMINOPHENAurohealth LLC57bb1acc-b9a0-48cd-8e5c-33712441ce812023-11-29WarningsExact identifier
application number: M013
Acetaminophen Regular StrengthACETAMINOPHENAurohealth LLCcc0ab7a1-e535-4dc8-962f-c58949fc17372023-11-29WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENAurohealth LLCa4ff94b9-c248-4cd3-8491-38e9555cc22e2023-11-29WarningsExact identifier
application number: M013
Aurophen Extra Strength for AdultsACETAMINOPHENAurohealth LLCd59c5f04-4bcc-4a52-a42f-e049506f00de2023-11-29WarningsExact identifier
application number: M013
Aurophen Extra Strength for AdultsACETAMINOPHENAurohealth LLCa769094b-1e91-4ca7-ba67-21aa7e3129102023-11-29WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENAurohealth LLC30756257-f748-4a5d-b031-dd267d0f91ad2023-11-29WarningsExact identifier
application number: M013
Aurophen Regular StrengthACETAMINOPHENAurohealth LLC8eda893f-5266-4b7a-95b9-2e194973cf062023-11-29WarningsExact identifier
application number: M013
Childrens Pain ReliefACETAMINOPHENAurohealth LLC00ec6518-b5e3-49d1-a342-139381c3bfd22023-11-29WarningsExact identifier
application number: M013
CHILDRENS PAIN RELIEFACETAMINOPHENBetter Living Brands, LLCfadb4c09-071f-56c0-e053-6294a90ae6c12023-11-28WarningsExact identifier
application number: M013
Acetaminophen and Diphenhydramine hydrochlorideACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDEBetter Living Brands, LLCfc07d516-9ffe-9989-e053-6294a90ae1a52023-11-28WarningsExact identifier
application number: M013
NOTTS - Tension HeadacheACETAMINOPHEN, CAFFEINEVIVUNT PHARMA LLC08f2ae03-967b-ad7e-e063-6294a90a84842023-11-24WarningsExact identifier
application number: M013
Sanatos Multi Symptoms NighttimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEPharmadel LLC0a60326a-a17b-e843-e063-6394a90ac2112023-11-22WarningsExact identifier
application number: M013
Sanatos Nighttime Multi SymptomsACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEPharmadel LLC0ab188f3-f7f9-d665-e063-6294a90a198a2023-11-22WarningsExact identifier
application number: M013
ASPIRINASPIRINTIME CAP LABS INCfe12519c-3e5f-4592-bd34-2d6b81b981f42023-11-22WarningsExact identifier
application number: M013
Rugby Regular Strength AcetaminophenACETAMINOPHENA-S Medication Solutions400d4a29-9e39-4e74-8272-37be5d7899242023-11-22WarningsExact identifier
application number: M013
RIGHT REMEDIES Pain Relief Extra Strength CapletACETAMINOPHENStrive Pharmaceuticals Inc.dcce28d9-8528-489e-b995-1d98e9d0e6ad2023-11-21WarningsExact identifier
application number: M013
Sanatos Multi Symptom DaytimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCIPharmadel LLC0ab11691-5b29-55fc-e063-6394a90aa3282023-11-17WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENA-S Medication Solutions1e223faa-f6d0-4235-bc4c-6cfca84a5b0a2023-11-17WarningsExact identifier
application number: M013
SanaTos XACETAMINOPHEN, DEXTROMETHORPHAN HBR,GUAIFENESIN, PHENYLEPHRINE HCIPharmadel LLC85b8ef3d-7318-7f3b-e053-2991aa0a07772023-11-14WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313820acetaminophen 160 MG Chewable TabletPSNc713556c-cb9e-4ed2-bc2f-49b3d6256c0f7
313820acetaminophen 160 MG Chewable TabletSCDc713556c-cb9e-4ed2-bc2f-49b3d6256c0f7
313820APAP 160 MG Chewable TabletSYc713556c-cb9e-4ed2-bc2f-49b3d6256c0f7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
37808-499-08378080499084 BLISTER PACK in 1 CARTON (37808-499-08) / 6 TABLET, CHEWABLE in 1 BLISTER PACK4 blister pack2022-02-090000-00-00NoNoCurrent