FDA.reportPublic FDA data

Childrens Acetaminophen

Product NDC
45802-201
11-digit product format
458020201
Labeler code
45802
Product ID
45802-201_4b6aba20-f288-4550-962e-c44eb8e077b1
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
SUSPENSION
Route
ORAL
Labeler
Padagis Israel Pharmaceuticals Ltd
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2014-04-09
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
Childrens Acetaminophen
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
a426dd82-b2d6-405e-b0af-cfb1310a6e19Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
75d4bef7-334c-4a95-abb5-bff9def24114Product name220260112
7dea7767-9f52-b60a-5435-33cb9cc28baeProduct name420250124
6338270f-96cb-0ecb-6fbb-0a9bc78001f4Product name720250116
11939cf5-0ea7-5df5-5127-00a7ce07fd7fProduct name520250115
0ca83774-3f79-b837-5d6f-c210102f3bc8Product name620250114
88300afc-e1c4-ad17-c80b-4957f1b809a5Product name520250113
4eddd6ca-259a-4c6c-a3a4-2025015ce043Product name720240611
16cde546-8deb-4df2-a072-dab5566ede95Product name120231003
20ab58de-c64a-4ec2-9210-3aa3fae2b66fProduct name120230808
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
a3631b20-02d1-41d7-8187-5e5e850b9e80Product name120230306
79e1734e-f721-4d46-978a-be382f771672Product name220230110
41b814f3-0166-1c53-c9ef-a0794c7daf9dProduct name320221110
a590be26-846c-8659-a5a1-fb25907965dcProduct name220221110
06cc817f-60e0-4473-8e6b-c44d11dc5af6Product name920220921
92ead9ae-674d-4eee-a492-c385d496891fProduct name320220308
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
103b151b-b17f-42ac-8624-3ef62f5e2975Product name220200507
b8497372-efe9-9dde-fa2d-59be9761aa64Product name920200428
20c8cafe-5cfc-44f8-a9be-a664f437f780Product name220200225
3a16d77a-e865-468a-aedf-6e58913c1c21Product name320190619
2a0c98e1-033f-4e0d-a0da-b5291ffbe880Product name120190320
00d531e4-b130-8c52-eaf9-826cbb6f15ddProduct name320190205
aa0f353d-f35e-62e4-4e1f-5b563f01c659Product name920190205
22d922aa-c443-d9f3-b23c-03b03a9ad31cProduct name720181220
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
377068df-225f-7318-a910-a1987cdfa361Product name320170608
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
23475c0b-a5b5-4fec-b97f-acca901eae6aProduct name120140718
105ef617-6fa4-6713-326f-72ec8a6b75a9Product name120140508
332e86c3-7875-ca6e-f934-2206d2b31996Product name120140508
3ed6b849-48b8-8899-c288-6eeb396123b6Product name120140508
47fd879b-91c5-e1e5-130f-29d082a871ecProduct name120140508
53855190-7124-8179-f018-e792f7c27f28Product name120140508
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
7dfac40f-a405-cd2e-7c06-3059ec0e1092Product name120140508
84fb0b3d-1d72-b672-bc70-2b676a23e7e0Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
96c5169b-5b9d-547d-bf22-d688d91866e4Product name120140508
b8e0daf1-fb81-290b-c0bf-873be19ef775Product name120140508
c35d1ac8-8885-2ee1-6c52-5a715b242c00Product name120140508
c8753a88-edde-8e17-a396-705537b52ceeProduct name120140508
cd4f9ae2-1343-ecd2-ce0f-97db0c2b51ceProduct name120140508
cf3a804d-0326-aa22-0142-c184b5657d85Product name120140508
d83c592c-dd97-4cbf-36ac-13da806684bdProduct name120140508
e01133ad-4dcd-c7f3-454b-2ff569ee160aProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
45802-201-26Childrens Acetaminophen118 mL in 1 BOTTLESUSPENSION1187
45802-201-26Childrens Acetaminophen1 in 1 CARTONSUSPENSION17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
45802-201-26ML - Milliliter45802-2015d2984f1-9132-42d9-9793-4fdce9ebe35112014-06-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DCHILDRENS ACETAMINOPHEN (ACETAMINOPHEN) SUSPENSION [PERRIGO NEW YORK INC]2
ACETAMINOPHENACTIVE MOIETY362O9ITL9DCHILDRENS ACETAMINOPHEN (ACETAMINOPHEN) SUSPENSION [PERRIGO NEW YORK INC]2
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLCHILDRENS ACETAMINOPHEN (ACETAMINOPHEN) SUSPENSION [PERRIGO NEW YORK INC]2
BUTYLPARABENINACTIVE INGREDIENT3QPI1U3FV8CHILDRENS ACETAMINOPHEN (ACETAMINOPHEN) SUSPENSION [PERRIGO NEW YORK INC]2
CALCIUM SULFATEINACTIVE INGREDIENTWAT0DDB505CHILDRENS ACETAMINOPHEN (ACETAMINOPHEN) SUSPENSION [PERRIGO NEW YORK INC]2
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS311CHILDRENS ACETAMINOPHEN (ACETAMINOPHEN) SUSPENSION [PERRIGO NEW YORK INC]2
CARRAGEENANINACTIVE INGREDIENT5C69YCD2YJCHILDRENS ACETAMINOPHEN (ACETAMINOPHEN) SUSPENSION [PERRIGO NEW YORK INC]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCHILDRENS ACETAMINOPHEN (ACETAMINOPHEN) SUSPENSION [PERRIGO NEW YORK INC]2
D&C RED NO. 33INACTIVE INGREDIENT9DBA0SBB0LCHILDRENS ACETAMINOPHEN (ACETAMINOPHEN) SUSPENSION [PERRIGO NEW YORK INC]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDCHILDRENS ACETAMINOPHEN (ACETAMINOPHEN) SUSPENSION [PERRIGO NEW YORK INC]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXCHILDRENS ACETAMINOPHEN (ACETAMINOPHEN) SUSPENSION [PERRIGO NEW YORK INC]2
HIGH FRUCTOSE CORN SYRUPINACTIVE INGREDIENTXY6UN3QB6SCHILDRENS ACETAMINOPHEN (ACETAMINOPHEN) SUSPENSION [PERRIGO NEW YORK INC]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3CHILDRENS ACETAMINOPHEN (ACETAMINOPHEN) SUSPENSION [PERRIGO NEW YORK INC]2
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUCHILDRENS ACETAMINOPHEN (ACETAMINOPHEN) SUSPENSION [PERRIGO NEW YORK INC]2
SODIUM PHOSPHATE, TRIBASICINACTIVE INGREDIENTA752Q30A6XCHILDRENS ACETAMINOPHEN (ACETAMINOPHEN) SUSPENSION [PERRIGO NEW YORK INC]2
SORBITOLINACTIVE INGREDIENT506T60A25RCHILDRENS ACETAMINOPHEN (ACETAMINOPHEN) SUSPENSION [PERRIGO NEW YORK INC]2
WATERINACTIVE INGREDIENT059QF0KO0RCHILDRENS ACETAMINOPHEN (ACETAMINOPHEN) SUSPENSION [PERRIGO NEW YORK INC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45802-201CHILDRENS ACETAMINOPHEN (ACETAMINOPHEN) SUSPENSION [PADAGIS ISRAEL PHARMACEUTICALS LTD]7Current NDC, Legacy NDC, 2 package rows20240702_a426dd82-b2d6-405e-b0af-cfb1310a6e19.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 73 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PANADOL ExtraACETAMINOPHEN AND CAFFEINEHaleon US Holdings LLCe5c2d88a-d903-4ca0-b895-f27e791dfc4e2024-02-06WarningsExact identifier
application number: M013
PANADOL Extra StrengthACETAMINOPHENHaleon US Holdings LLCb2fe7f47-1a2e-40ee-8f8f-38f2028dce1b2024-02-06WarningsExact identifier
application number: M013
PANADOL Extra StrengthACETAMINOPHENHaleon US Holdings LLC9d384e88-5c11-4600-ac6c-a383715701382024-02-06WarningsExact identifier
application number: M013
PANADOLACETAMINOPHENHaleon US Holdings LLC95801755-db54-4ad7-bec1-52671914f6ca2024-02-06WarningsExact identifier
application number: M013
PANADOL PMACETAMINOPHEN AND DIPHENHYDRAMINE HCLHaleon US Holdings LLC01e7dddb-755c-4745-b701-edcdb62090642024-02-06Warnings, Adverse reactionsExact identifier
application number: M013
PANADOL PMACETAMINOPHEN AND DIPHENHYDRAMINE HCLHaleon US Holdings LLCfe7cd1f2-9b00-4ded-99c2-8a152c71093c2024-02-06Warnings, Adverse reactionsExact identifier
application number: M013
Childrens Pain and FeverACETAMINOPHENAptaPharma Inc.9064943f-836f-4853-b6f2-2c4879941eeb2024-02-02WarningsExact identifier
application number: M013
Quality Choice Effervescent Pain ReliefASPIRINCHAIN DRUG MARKETING ASSOCIATION, INC.079af5d7-1be8-2a93-e063-6294a90a496d2024-02-01WarningsExact identifier
application number: M013
MEDI-FIRST Non-AspirinACETAMINOPHENProficient Rx LP4c84948d-3a95-4c53-8529-7e7b9d8bb6df2024-02-01WarningsExact identifier
application number: M013
PharbetolACETAMINOPHENProficient Rx LP9c7d65e4-df2f-47c1-a185-66aaf19aad2b2024-02-01WarningsExact identifier
application number: M013
Childrens AcetaminophenACETAMINOPHENProficient Rx LP57e4820c-b4eb-442e-9c49-93eedfbc5e5e2024-02-01WarningsExact identifier
application number: M013
good sense aspirinASPIRINProficient Rx LP73013074-9c6e-43c7-acde-4d9d8ed0133d2024-02-01WarningsExact identifier
application number: M013
MEDIQUE APAP Extra StrengthACETAMINOPHENProficient Rx LPc466a07f-2339-4cf5-8377-e0f109649c522024-02-01WarningsExact identifier
application number: M013
Percogesic Extra StrengthACETAMINOPHEN AND DIPHENHYDRAMINEMedtech Products Inc.2c5f1140-fb83-42c9-b0b1-5e2bd69340bb2024-02-01WarningsExact identifier
application number: M013
aspirinASPIRINProficient Rx LP3c7783a7-2b28-4968-b766-0a49dc70ce6d2024-02-01WarningsExact identifier
application number: M013
Regular Strength Pain ReliefACETAMINOPHENNuCare Pharmaceuticals,Inc.102bdcde-cb90-f248-e063-6394a90aac792024-01-30WarningsExact identifier
application number: M013
Excedrin Extra Strength HeadacheACETAMINOPHEN, ASPIRIN (NSAID), CAFFEINEHaleon US Holdings LLC61802b27-c9ec-4386-9d44-45e8b1e558b72024-01-28WarningsExact identifier
application number: M013
AGRIFENACETAMINOPHEN, ASPIRIN, CAFFEINEOPMX LLC0fde22da-cdfc-36cc-e063-6294a90a38852024-01-26WarningsExact identifier
application number: M013
DOLODOLACETAMINOPHEN, ASPIRIN, CAFFEINEOPMX LLCe80536f1-92cc-5bb3-e053-2995a90a95402024-01-26WarningsExact identifier
application number: M013
LOW DOSE ASPIRINASPIRINBryant Ranch Prepackd913d11f-c7a1-49d2-a2d3-9a29fc0328062024-01-18WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
307668acetaminophen 160 MG in 5 mL Oral SuspensionPSN190bb2dc-92b4-4b59-a47f-a0251df8261c100
307668acetaminophen 32 MG/ML Oral SuspensionSCD190bb2dc-92b4-4b59-a47f-a0251df8261c100
307668acetaminophen 160 MG per 5 ML Oral SuspensionSY190bb2dc-92b4-4b59-a47f-a0251df8261c100
307668acetaminophen 320 MG per 10 ML Oral SuspensionSY190bb2dc-92b4-4b59-a47f-a0251df8261c100
307668acetaminophen 650 MG per 20.3 ML Oral SuspensionSY190bb2dc-92b4-4b59-a47f-a0251df8261c100
307668acetaminophen 80 MG per 2.5 ML Oral SuspensionSY190bb2dc-92b4-4b59-a47f-a0251df8261c100
307668APAP 32 MG/ML Oral SuspensionSY190bb2dc-92b4-4b59-a47f-a0251df8261c100
307668acetaminophen 160 MG in 5 mL Oral SuspensionPSNa426dd82-b2d6-405e-b0af-cfb1310a6e197
307668acetaminophen 32 MG/ML Oral SuspensionSCDa426dd82-b2d6-405e-b0af-cfb1310a6e197
307668acetaminophen 160 MG per 5 ML Oral SuspensionSYa426dd82-b2d6-405e-b0af-cfb1310a6e197
307668acetaminophen 320 MG per 10 ML Oral SuspensionSYa426dd82-b2d6-405e-b0af-cfb1310a6e197
307668acetaminophen 650 MG per 20.3 ML Oral SuspensionSYa426dd82-b2d6-405e-b0af-cfb1310a6e197
307668acetaminophen 80 MG per 2.5 ML Oral SuspensionSYa426dd82-b2d6-405e-b0af-cfb1310a6e197
307668APAP 32 MG/ML Oral SuspensionSYa426dd82-b2d6-405e-b0af-cfb1310a6e197
307668acetaminophen 160 MG in 5 mL Oral SuspensionPSNbdc466c9-d9ae-4293-b7ea-46fb517661c65
307668acetaminophen 160 MG in 5 mL Oral SuspensionPSN57e4820c-b4eb-442e-9c49-93eedfbc5e5e5
307668acetaminophen 32 MG/ML Oral SuspensionSCDbdc466c9-d9ae-4293-b7ea-46fb517661c65
307668acetaminophen 32 MG/ML Oral SuspensionSCD57e4820c-b4eb-442e-9c49-93eedfbc5e5e5
307668acetaminophen 160 MG per 5 ML Oral SuspensionSYbdc466c9-d9ae-4293-b7ea-46fb517661c65
307668acetaminophen 160 MG per 5 ML Oral SuspensionSY57e4820c-b4eb-442e-9c49-93eedfbc5e5e5
307668acetaminophen 320 MG per 10 ML Oral SuspensionSY57e4820c-b4eb-442e-9c49-93eedfbc5e5e5
307668acetaminophen 320 MG per 10 ML Oral SuspensionSYbdc466c9-d9ae-4293-b7ea-46fb517661c65
307668acetaminophen 650 MG per 20.3 ML Oral SuspensionSY57e4820c-b4eb-442e-9c49-93eedfbc5e5e5
307668acetaminophen 650 MG per 20.3 ML Oral SuspensionSYbdc466c9-d9ae-4293-b7ea-46fb517661c65
307668acetaminophen 80 MG per 2.5 ML Oral SuspensionSY57e4820c-b4eb-442e-9c49-93eedfbc5e5e5
307668acetaminophen 80 MG per 2.5 ML Oral SuspensionSYbdc466c9-d9ae-4293-b7ea-46fb517661c65
307668APAP 32 MG/ML Oral SuspensionSY57e4820c-b4eb-442e-9c49-93eedfbc5e5e5
307668APAP 32 MG/ML Oral SuspensionSYbdc466c9-d9ae-4293-b7ea-46fb517661c65
307668acetaminophen 160 MG in 5 mL Oral SuspensionPSN68e214cd-2d09-42d0-a4e9-b1b81af6be3c4
307668acetaminophen 32 MG/ML Oral SuspensionSCD68e214cd-2d09-42d0-a4e9-b1b81af6be3c4
307668acetaminophen 160 MG per 5 ML Oral SuspensionSY68e214cd-2d09-42d0-a4e9-b1b81af6be3c4
307668acetaminophen 320 MG per 10 ML Oral SuspensionSY68e214cd-2d09-42d0-a4e9-b1b81af6be3c4
307668acetaminophen 650 MG per 20.3 ML Oral SuspensionSY68e214cd-2d09-42d0-a4e9-b1b81af6be3c4
307668acetaminophen 80 MG per 2.5 ML Oral SuspensionSY68e214cd-2d09-42d0-a4e9-b1b81af6be3c4
307668APAP 32 MG/ML Oral SuspensionSY68e214cd-2d09-42d0-a4e9-b1b81af6be3c4
307668acetaminophen 160 MG in 5 mL Oral SuspensionPSN872365ca-0c6b-550a-e053-2a91aa0ab25a3
307668acetaminophen 32 MG/ML Oral SuspensionSCD872365ca-0c6b-550a-e053-2a91aa0ab25a3
307668acetaminophen 160 MG per 5 ML Oral SuspensionSY872365ca-0c6b-550a-e053-2a91aa0ab25a3
307668acetaminophen 320 MG per 10 ML Oral SuspensionSY872365ca-0c6b-550a-e053-2a91aa0ab25a3
307668acetaminophen 650 MG per 20.3 ML Oral SuspensionSY872365ca-0c6b-550a-e053-2a91aa0ab25a3
307668acetaminophen 80 MG per 2.5 ML Oral SuspensionSY872365ca-0c6b-550a-e053-2a91aa0ab25a3
307668APAP 32 MG/ML Oral SuspensionSY872365ca-0c6b-550a-e053-2a91aa0ab25a3
307668acetaminophen 160 MG in 5 mL Oral SuspensionPSNcc2f53bb-28cf-4a2f-b8b2-0c64fd2744342
307668acetaminophen 32 MG/ML Oral SuspensionSCDcc2f53bb-28cf-4a2f-b8b2-0c64fd2744342
307668acetaminophen 160 MG per 5 ML Oral SuspensionSYcc2f53bb-28cf-4a2f-b8b2-0c64fd2744342
307668acetaminophen 320 MG per 10 ML Oral SuspensionSYcc2f53bb-28cf-4a2f-b8b2-0c64fd2744342
307668acetaminophen 650 MG per 20.3 ML Oral SuspensionSYcc2f53bb-28cf-4a2f-b8b2-0c64fd2744342
307668acetaminophen 80 MG per 2.5 ML Oral SuspensionSYcc2f53bb-28cf-4a2f-b8b2-0c64fd2744342
307668APAP 32 MG/ML Oral SuspensionSYcc2f53bb-28cf-4a2f-b8b2-0c64fd2744342
307668acetaminophen 160 MG in 5 mL Oral SuspensionPSN2f3682d3-c6c3-433a-b06e-3e7370eb875a1
307668acetaminophen 32 MG/ML Oral SuspensionSCD2f3682d3-c6c3-433a-b06e-3e7370eb875a1
307668acetaminophen 160 MG per 5 ML Oral SuspensionSY2f3682d3-c6c3-433a-b06e-3e7370eb875a1
307668acetaminophen 320 MG per 10 ML Oral SuspensionSY2f3682d3-c6c3-433a-b06e-3e7370eb875a1
307668acetaminophen 650 MG per 20.3 ML Oral SuspensionSY2f3682d3-c6c3-433a-b06e-3e7370eb875a1
307668acetaminophen 80 MG per 2.5 ML Oral SuspensionSY2f3682d3-c6c3-433a-b06e-3e7370eb875a1
307668APAP 32 MG/ML Oral SuspensionSY2f3682d3-c6c3-433a-b06e-3e7370eb875a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
45802-201-26458020201261 BOTTLE in 1 CARTON (45802-201-26) / 118 mL in 1 BOTTLE1 bottle2014-04-090000-00-00NoNoCurrent