FDA.reportPublic FDA data

Childrens Mapap

Product NDC
0904-5791
11-digit product format
009045791
Labeler code
0904
Product ID
0904-5791_2bd5ccbd-a062-4af1-bc34-99498594c2ba
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
Major Pharmaceuticals
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2004-12-06
Substance
ACETAMINOPHEN
Active strength
80 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 Mapap
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN80 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 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
209495Internal RxNorm lookup
307696Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
efec6af2-8b26-47f6-88c8-b0a6d69a2d7dAvailable 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
0904-5791-46Childrens Mapap30 in 1 BOTTLE, PLASTICTABLET, CHEWABLE3022
0904-5791-46Childrens Mapap1 in 1 CARTONTABLET, CHEWABLE122

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-5791-46EA - Each0904-5791ccb7c15f-a886-4b5c-abd3-3a13255dcfd212012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DCHILDRENS MAPAP (ACETAMINOPHEN) TABLET, CHEWABLE [MAJOR PHARMACEUTICALS]5
ACETAMINOPHENACTIVE MOIETY362O9ITL9DCHILDRENS MAPAP (ACETAMINOPHEN) TABLET, CHEWABLE [MAJOR PHARMACEUTICALS]5
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPCHILDRENS MAPAP (ACETAMINOPHEN) TABLET, CHEWABLE [MAJOR PHARMACEUTICALS]5
D&C RED NO. 27INACTIVE INGREDIENT2LRS185U6KCHILDRENS MAPAP (ACETAMINOPHEN) TABLET, CHEWABLE [MAJOR PHARMACEUTICALS]5
D&C RED NO. 30INACTIVE INGREDIENT2S42T2808BCHILDRENS MAPAP (ACETAMINOPHEN) TABLET, CHEWABLE [MAJOR PHARMACEUTICALS]5
ETHYLCELLULOSESINACTIVE INGREDIENT7Z8S9VYZ4BCHILDRENS MAPAP (ACETAMINOPHEN) TABLET, CHEWABLE [MAJOR PHARMACEUTICALS]5
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDCHILDRENS MAPAP (ACETAMINOPHEN) TABLET, CHEWABLE [MAJOR PHARMACEUTICALS]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CHILDRENS MAPAP (ACETAMINOPHEN) TABLET, CHEWABLE [MAJOR PHARMACEUTICALS]5
MANNITOLINACTIVE INGREDIENT3OWL53L36ACHILDRENS MAPAP (ACETAMINOPHEN) TABLET, CHEWABLE [MAJOR PHARMACEUTICALS]5
POVIDONESINACTIVE INGREDIENTFZ989GH94ECHILDRENS MAPAP (ACETAMINOPHEN) TABLET, CHEWABLE [MAJOR PHARMACEUTICALS]5
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APCHILDRENS MAPAP (ACETAMINOPHEN) TABLET, CHEWABLE [MAJOR PHARMACEUTICALS]5
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD4CHILDRENS MAPAP (ACETAMINOPHEN) TABLET, CHEWABLE [MAJOR PHARMACEUTICALS]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-5791CHILDRENS MAPAP (ACETAMINOPHEN) TABLET, CHEWABLE [MAJOR PHARMACEUTICALS]20Current NDC, Legacy NDC, 2 package rows20250116_efec6af2-8b26-47f6-88c8-b0a6d69a2d7d.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 74 of 79 · 1,576 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Extra Strength Acetaminophen PMACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDEKROGER COMPANY2560126e-a54a-4a47-9631-a1bca42f52772024-01-10WarningsExact identifier
application number: M013
LOW DOSE ASPIRINASPIRINA-S Medication Solutionsee4451c9-4d0f-4373-8f64-fcc1f9dd58562024-01-05WarningsExact identifier
application number: M013
PharbetolACETAMINOPHENProficient Rx LP51ba690e-d76b-41c6-a083-8bc803e1faa22024-01-01WarningsExact identifier
application number: M013
MEDI-FIRST Non-Aspirin Extra StrengthACETAMINOPHENProficient Rx LP9071b047-5463-4f65-b775-bfb0ce0665272024-01-01WarningsExact identifier
application number: M013
LOW DOSE ASPIRINASPIRINTIME CAP LABORATORIES, INC1acc8c1a-c746-4635-800c-de1ad758fce02023-12-30WarningsExact identifier
application number: M013
MAX Cold, Flu, and Sore ThroatACETAMINOPHEN,DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN , PHENYLEPHRINE HCLH E B9b09b660-0758-48dc-84c9-26cdd2aacc032023-12-29WarningsExact identifier
application number: M013
NIGHT-TIME MULTI-SYMPTOM COLD/FLU OriginalACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEDeMoulas Market Basketeb24323f-82a1-4ba3-9359-fe81571c3fba2023-12-29WarningsExact identifier
application number: M013
Nite-TimeCOLD/FLU CHERRY COLD/FLU CHERRYACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATESalado Sales, Inc.e6c3e545-b2ad-47f0-8318-c134a8e24f5b2023-12-29WarningsExact identifier
application number: M013
Daytime Non-Drowsy COLD/FLUACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDESalado Sales, Inc.e181b371-78c7-4163-865d-acc064be33ca2023-12-29WarningsExact identifier
application number: M013
Childrens Pain and Fever Cherry flavorACETAMINOPHENWalgreen Company64c65244-f7a3-401b-b83a-bf66d45268e22023-12-29WarningsExact identifier
application number: M013
Nite-Time COLD/FLU ORIGINALACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATESalado Sales, Inc.fcd24753-b42b-4d05-8379-0ec0351ab2172023-12-29WarningsExact identifier
application number: M013
NIGHT-TIME MULTI-SYMPTOM COLD/FLU CherryACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEDeMoulas Market Baskete772cdf5-d01d-4752-8cfb-7e7f4d7a8dd02023-12-29WarningsExact identifier
application number: M013
Childrens Pain and Fever, Grape flavorACETAMINOPHENWalgreen Company0995d69f-61aa-40b0-b095-bb8595caf7732023-12-29WarningsExact identifier
application number: M013
DAY-TIME Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEDeMoulas Market Basketce900e42-d0c8-408d-a1c3-3a9bef1c97ee2023-12-29WarningsExact identifier
application number: M013
Pain Relief PMACETAMINOPHEN, DIPHENHYDRAMINE HCLDOLGENCORP, INC.06553550-5685-f3c3-e063-6394a90aef072023-12-22WarningsExact identifier
application number: M013
Tension Headache Pain Relieving AidACETAMINOPHEN,CAFFEINEWAL-MART STORES INC00fadd26-a6eb-dc5e-e063-6394a90a3cca2023-12-15WarningsExact identifier
application number: M013
Dye-Free Aspirin 81ASPIRINWALGREENSd71a9d3a-cd28-14a8-e053-2995a90a832b2023-12-15WarningsExact identifier
application number: M013
Lil Drug Store Aspirin 325ASPIRINLil Drug Store Products, Incde59aae2-f794-4243-acc8-37a10e27abde2023-12-15WarningsExact identifier
application number: M013
Pain RelieverACETAMINOPHEN TABLET, EXTRA STRENGTHLil' Drug Store Products, Inc.f0fdab5a-9d07-57aa-e053-2a95a90adc7f2023-12-15WarningsExact identifier
application number: M013
BC CherryASPIRIN AND CAFFEINELil' Drug Store Products, Inc79ea721b-d656-44f7-9d13-390debee7be02023-12-15WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
307696acetaminophen 80 MG Chewable TabletPSNefec6af2-8b26-47f6-88c8-b0a6d69a2d7d22
209495Mapap Children's 80 MG Chewable TabletPSNefec6af2-8b26-47f6-88c8-b0a6d69a2d7d22
209495acetaminophen 80 MG Chewable Tablet [Mapap]SBDefec6af2-8b26-47f6-88c8-b0a6d69a2d7d22
307696acetaminophen 80 MG Chewable TabletSCDefec6af2-8b26-47f6-88c8-b0a6d69a2d7d22
307696APAP 80 MG Chewable TabletSYefec6af2-8b26-47f6-88c8-b0a6d69a2d7d22
209495APAP 80 MG Chewable Tablet [Mapap]SYefec6af2-8b26-47f6-88c8-b0a6d69a2d7d22
209495Children's Chewable Mapap 80 MG Chewable TabletSYefec6af2-8b26-47f6-88c8-b0a6d69a2d7d22
209495Mapap 80 MG Chewable TabletSYefec6af2-8b26-47f6-88c8-b0a6d69a2d7d22
307696acetaminophen 80 MG Chewable TabletPSN69c90cc8-846a-42cf-933a-108671689e8f6
209495Mapap Children's 80 MG Chewable TabletPSN69c90cc8-846a-42cf-933a-108671689e8f6
209495acetaminophen 80 MG Chewable Tablet [Mapap]SBD69c90cc8-846a-42cf-933a-108671689e8f6
307696acetaminophen 80 MG Chewable TabletSCD69c90cc8-846a-42cf-933a-108671689e8f6
307696APAP 80 MG Chewable TabletSY69c90cc8-846a-42cf-933a-108671689e8f6
209495APAP 80 MG Chewable Tablet [Mapap]SY69c90cc8-846a-42cf-933a-108671689e8f6
209495Children's Chewable Mapap 80 MG Chewable TabletSY69c90cc8-846a-42cf-933a-108671689e8f6
209495Mapap 80 MG Chewable TabletSY69c90cc8-846a-42cf-933a-108671689e8f6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0904-5791-46009045791461 BOTTLE, PLASTIC in 1 CARTON (0904-5791-46) / 30 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC2004-12-060000-00-00NoNoCurrent