Pain Reliever

Product NDC
37808-945
11-digit product format
378080945
Labeler code
37808
Product ID
37808-945_e5cba1ae-084a-4e81-8a3c-1e13aed8c9b0
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
2005-02-25
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
Pain Reliever
Brand name suffix
Childrens
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
7e43de11-d20b-4920-a04d-3c1b5d35e005Available 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
37808-945-08Pain RelieverChildrens6 in 1 BLISTER PACKTABLET, CHEWABLE610
37808-945-08Pain RelieverChildrens4 in 1 CARTONTABLET, CHEWABLE410

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
37808-945PAIN RELIEVER CHILDRENS (ACETAMINOPHEN) TABLET, CHEWABLE [H E B]9Current NDC, Legacy NDC, 2 package rows20250427_7e43de11-d20b-4920-a04d-3c1b5d35e005.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 47 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GOOD REMEDIES Extra Strength Pain Relief PM CapletACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDEStrive Pharmaceuticals Inc.2d642d8e-c154-a970-e063-6294a90a03bf2025-03-14WarningsExact identifier
application number: M013
Pain ReliefACETAMINOPHENDISCOUNT DRUG MART97f78c4a-9d0d-4fe1-8b2b-d5f8ab939ac42025-03-07WarningsExact identifier
application number: M013
Redicare Non-Aspirin 500mgREDICARE NON-ASPIRIN, ACETAMINOPHEN 500MGRedicare LLC2f229898-1777-732c-e063-6394a90a76bc2025-03-04Warnings, Adverse reactionsExact identifier
application number: M013
Major Extra Strength Acetaminophen LiquidACETAMINOPHENMajor Pharmaceuticals2f3af4dd-45d5-87b4-e063-6294a90ab3cc2025-02-28WarningsExact identifier
application number: M013
LOW DOSE ASPIRINASPIRINNCS HealthCare of KY, LLC dba Vangard Labsed9a71d6-a56e-416a-bb89-6d41307efc5a2025-02-27WarningsExact identifier
application number: M013
AspirinASPIRINPD-Rx Pharmaceuticals, Inc.77429b7f-78e4-42c0-8679-ae8da17488482025-02-26WarningsExact identifier
application number: M013
AeroTab Non-AspirinACETAMINOPHEN 500MG ESAero Healthcarefaa3a4ef-3c70-06ca-e053-6394a90a512d2025-02-26WarningsExact identifier
application number: M013
Bufferin Regular Strength Pain ReliefASPIRINGenomma Lab USA3543b2bf-1062-468a-a5dc-eabb2408af8c2025-02-25WarningsExact identifier
application number: M013
Calmour Childrens Acetaminophen Strips ChewableACETAMINOPHEN ORAL CHEWABLE 80 MGCalmourae47b027-4f29-45bb-a8bd-8129789328352025-02-22WarningsExact identifier
application number: M013
Infants TYLENOLACETAMINOPHENKenvue Brands LLCf9de7c2f-016b-4f40-8b5e-141ad194be972025-02-20WarningsExact identifier
application number: M013
Genexa Acetaminophen PM Extra StrengthACETAMINOPHENGenexa Inc.d82cf6f3-a291-ca2b-e053-2a95a90a6de12025-02-20WarningsExact identifier
application number: M013
Childrens AcetaminophenACETAMINOPHENAdvagen Pharma Limited8b9456c9-a56b-4748-adb8-c66d6bf072e82025-02-19WarningsExact identifier
application number: M013
Genexa Childrens AcetaminophenACETAMINOPHENGenexa Inc.d89fd9d8-d88e-3968-e053-2a95a90afc5f2025-02-19WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENPrecision Dose, Inc.debfa787-7a48-48b5-94b0-6128205240322025-02-19WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENPrecision Dose, Inc.b16e5dcf-b290-4ff2-a150-4b875647ec9a2025-02-19WarningsExact identifier
application number: M013
TYLENOL Extra StrengthACETAMINOPHENKenvue Brands LLCbb6533e5-e6a9-488c-b8ab-a6a06e87ede92025-02-18WarningsExact identifier
application number: M013
TYLENOL Extra StrengthACETAMINOPHENKenvue Brands LLCc830320e-72ba-48ff-a4cd-250ac5650bf02025-02-18WarningsExact identifier
application number: M013
Aspirina CapletsASPIRINBayer HealthCare LLC.2e6f5ba8-8e8b-6059-e063-6394a90adcd52025-02-18WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENPD-Rx Pharmaceuticals, Inc.da7d95af-6583-429d-8d04-e0424f32e9ad2025-02-17WarningsExact identifier
application number: M013
GOODYS Mental AlertASPIRIN AND CAFFEINEMedtech Products Inc.31ef6d07-d314-4d09-abcd-389ba66cbcc52025-02-17WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313820acetaminophen 160 MG Chewable TabletPSN7e43de11-d20b-4920-a04d-3c1b5d35e00510
313820acetaminophen 160 MG Chewable TabletSCD7e43de11-d20b-4920-a04d-3c1b5d35e00510
313820APAP 160 MG Chewable TabletSY7e43de11-d20b-4920-a04d-3c1b5d35e00510

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
37808-945-08378080945084 BLISTER PACK in 1 CARTON (37808-945-08) / 6 TABLET, CHEWABLE in 1 BLISTER PACK4 blister pack2005-02-250000-00-00NoNoCurrent