FDA.reportPublic FDA data

CHILDRENS Acetaminophen

Product NDC
81033-026
11-digit product format
810330026
Labeler code
81033
Product ID
81033-026_4af5ab0d-3ee5-fad5-e063-6294a90a4f41
Type
HUMAN OTC DRUG
Nonproprietary name
CHILDRENS Acetaminophen
Dosage form
SUSPENSION
Route
ORAL
Labeler
Kesin Pharma Corporation
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-02-27
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 Acetaminophen
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
4af5b025-1fd7-e825-e063-6294a90aa005Available 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
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
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
377068df-225f-7318-a910-a1987cdfa361Product name320170608
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
7dfac40f-a405-cd2e-7c06-3059ec0e1092Product name120140508
84fb0b3d-1d72-b672-bc70-2b676a23e7e0Product 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
81033-026-01CHILDRENS Acetaminophen100 in 1 CASESUSPENSION1001
81033-026-02CHILDRENS Acetaminophen100 in 1 CASESUSPENSION1001
81033-026-05CHILDRENS Acetaminophen5 mL in 1 CUP, UNIT-DOSESUSPENSION51
81033-026-10CHILDRENS Acetaminophen10.15 mL in 1 CUP, UNIT-DOSESUSPENSION10.151
81033-026-20CHILDRENS Acetaminophen20.13 mL in 1 CUP, UNIT-DOSESUSPENSION20.131
81033-026-38CHILDRENS Acetaminophen30 in 1 CARTONSUSPENSION301
81033-026-39CHILDRENS Acetaminophen30 in 1 CARTONSUSPENSION301
81033-026-40CHILDRENS Acetaminophen30 in 1 CARTONSUSPENSION301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
81033-026-01ML - Milliliter81033-026815badbb-ba6d-4650-a528-bbcdce1160c612026-05-22
81033-026-02ML - Milliliter81033-02676bab1c1-688c-46f9-88dd-9c63bd7d37f612026-05-22
81033-026-05ML - Milliliter81033-0265966282c-f74e-4cfc-b914-4e9007043db812026-05-22
81033-026-10ML - Milliliter81033-026460a25d6-a7e4-40c7-9989-10a2ccaa673e12026-05-22
81033-026-38ML - Milliliter81033-0260bf568cb-1e68-4de6-8be4-9bd4427573c312026-05-22
81033-026-39ML - Milliliter81033-0261a8eb325-d55f-44f7-a802-bf24995e442212026-05-22

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 77 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
RIGHT REMEDIES EXTRA STRENGTH PM Pain ReliefACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDEStrive Pharmaceuticals Inc.8badbaad-eb35-4251-a779-00474819360d2023-11-13WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENTrifecta Pharmaceuticals USA LLC09935a74-34b0-0e7c-e063-6294a90a7c832023-11-07WarningsExact identifier
application number: M013
Pain Relief PMACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDEAMERIFOODS TRADING COMPANYf6dd6396-93e9-1096-e053-6394a90af06d2023-11-02WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENRETAIL BUSINESS SERVICES , LLC.eb644e9e-36dc-5f84-e053-2a95a90affa52023-11-02WarningsExact identifier
application number: M013
Good Sense Childrens Pain and FeverACETAMINOPHENProficient Rx LP46527b1f-7515-44ce-b5cb-9d24223b9af12023-11-01WarningsExact identifier
application number: M013
AspirinASPIRINA-S Medication Solutions12feb32b-4b8c-4b17-9e86-cb286457b0882023-11-01WarningsExact identifier
application number: M013
Acetaminophen, Aspirin, CaffeineACETAMINOPHEN, ASPIRIN, CAFFEINEProficient Rx LPaf8b30a0-7a56-4557-8404-cc8059fcd6bc2023-11-01WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENAMERIFOODS TRADING COMPANYf6dd387d-c768-9443-e053-6394a90aca142023-10-31WarningsExact identifier
application number: M013
ASPIRINASPIRINAMERIFOODS TRADING COMPANYf6cec280-17a5-5c5d-e053-6394a90a81aa2023-10-31WarningsExact identifier
application number: M013
Regular Strength AspirinASPIRINCARDINAL HEALTH, INC.8aaa82c6-b46b-25c5-e053-2a95a90a37932023-10-30WarningsExact identifier
application number: M013
SafeTynadolACETAMINOPHENSinew Pharma Inc.b956d527-7ea7-e084-e053-2a95a90a866d2023-10-28WarningsExact identifier
application number: M013
Pain Reliever PMACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDEMagno-Humphries, Inc.9d2275c8-0c3d-d2b3-e053-2995a90a368e2023-10-27WarningsExact identifier
application number: M013
Pain RelieverACETAMINOPHENMagno-Humphries, Inc.9d22bedb-9fb3-8421-e053-2a95a90acf4a2023-10-27WarningsExact identifier
application number: M013
Acetaminophen Regular StrengthACETAMINOPHENMagno-Humphries, Inc.9d22d642-8aaf-d17e-e053-2995a90ae1822023-10-27WarningsExact identifier
application number: M013
ENTERIC COATED ASPIRINASPIRINMagno-Humphries, Inc.a7c02378-4213-4e57-aca2-2437ad02f7862023-10-27WarningsExact identifier
application number: M013
ExtraprinACETAMINOPHEN, ASPIRIN, CAFFEINEMagno-Humphries, Inc.9d22cdc8-29c5-4273-e053-2a95a90ad0bf2023-10-27WarningsExact identifier
application number: M013
Regular Strength Enteric coated aspirinASPIRINGeri-Care Pharmaceutical Corpc321208c-f192-42c5-9454-e0df5d02d6852023-10-26WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
307668acetaminophen 160 MG in 5 mL Oral SuspensionPSN4af5b025-1fd7-e825-e063-6294a90aa0051
307668acetaminophen 32 MG/ML Oral SuspensionSCD4af5b025-1fd7-e825-e063-6294a90aa0051
307668acetaminophen 160 MG per 5 ML Oral SuspensionSY4af5b025-1fd7-e825-e063-6294a90aa0051
307668acetaminophen 320 MG per 10 ML Oral SuspensionSY4af5b025-1fd7-e825-e063-6294a90aa0051
307668acetaminophen 650 MG per 20.3 ML Oral SuspensionSY4af5b025-1fd7-e825-e063-6294a90aa0051
307668acetaminophen 80 MG per 2.5 ML Oral SuspensionSY4af5b025-1fd7-e825-e063-6294a90aa0051
307668APAP 32 MG/ML Oral SuspensionSY4af5b025-1fd7-e825-e063-6294a90aa0051

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
81033-026-0181033002601100 CUP, UNIT-DOSE in 1 CASE (81033-026-01) / 5 mL in 1 CUP, UNIT-DOSE (81033-026-05) 2026-02-27NoNoCurrent
81033-026-0281033002602100 CUP, UNIT-DOSE in 1 CASE (81033-026-02) / 10.15 mL in 1 CUP, UNIT-DOSE (81033-026-10) 2026-02-27NoNoCurrent
81033-026-05810330026055 mL in 1 CUP, UNIT-DOSE (81033-026-05) 5 ml2026-02-27NoNoCurrent
81033-026-108103300261010.15 mL in 1 CUP, UNIT-DOSE (81033-026-10) 10.15 ml2026-02-27NoNoCurrent
81033-026-208103300262020.13 mL in 1 CUP, UNIT-DOSE (81033-026-20) 20.13 ml2026-02-27NoNoCurrent
81033-026-388103300263830 CUP, UNIT-DOSE in 1 CARTON (81033-026-38) / 5 mL in 1 CUP, UNIT-DOSE (81033-026-05) 2026-02-27NoNoCurrent
81033-026-398103300263930 CUP, UNIT-DOSE in 1 CARTON (81033-026-39) / 10.15 mL in 1 CUP, UNIT-DOSE (81033-026-10) 2026-02-27NoNoCurrent
81033-026-408103300264030 CUP, UNIT-DOSE in 1 CARTON (81033-026-40) / 20.13 mL in 1 CUP, UNIT-DOSE (81033-026-20) 2026-02-27NoNoCurrent