FDA.reportPublic FDA data

Childrens Acetaminophen

Product NDC
0121-1781
11-digit product format
001211781
Labeler code
0121
Product ID
0121-1781_5c063866-c8c4-4be2-abad-d09d279fc99f
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
SUSPENSION
Route
ORAL
Labeler
PAI Holdings, LLC dba PAI Pharma
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2007-09-17
Substance
ACETAMINOPHEN
Active strength
160 mg/5mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 14 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductDDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0121-1781-00DDiscontinued by firm367a005e9d99…383a685ebd0f…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductIInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage0121-1781-05IInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproductIInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage0121-1781-05IInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductIInactivated by FDAbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage0121-1781-05IInactivated by FDAbd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproductIInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage0121-1781-05IInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproductIInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage0121-1781-05IInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproductIInactivated by FDA9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage0121-1781-05IInactivated by FDA9bebd1f3094a…5416666fcb17…

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
46d9d8cd-e3db-492c-9386-7e8255beff64Available 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
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
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
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0121-1781-002021-08-23C16284748780-1ba0f9c33-13ad-a910-e053-dadaa90a0b85Children's Acetaminophen Oral Suspension Ibuprofen Free/Alcohol Free/Aspirin Free
0121-1781-002021-01-29C16284748780-1ba0f9c33-13ad-a910-e053-dadaa90a0b85Children's Acetaminophen Oral Suspension Ibuprofen Free/Alcohol Free/Aspirin Free
0121-1781-052020-01-31C16284748780-19d75b9d0-dd2f-f424-e053-dadaa90a57ceChildren's Acetaminophen

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0121-1781-00Childrens Acetaminophen10 in 1 CASESUSPENSION1013
0121-1781-00Childrens Acetaminophen10 in 1 TRAYSUSPENSION1013
0121-1781-05Childrens Acetaminophen5 mL in 1 CUP, UNIT-DOSESUSPENSION513

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0121-1781-00ML - Milliliter0121-1781216b7a39-3839-44f8-ba3a-cf40c805602912017-06-15
0121-1781-05ML - Milliliter0121-17819246f12e-a346-4cc7-95b3-f112f0c7685112015-02-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AcetaminophenACTIVE INGREDIENT362O9ITL9DCHILDRENS ACETAMINOPHEN (ACETAMINOPHEN) SUSPENSION [PHARMACEUTICAL ASSOCIATES, INC.]1
AcetaminophenACTIVE MOIETY362O9ITL9DCHILDRENS ACETAMINOPHEN (ACETAMINOPHEN) SUSPENSION [PHARMACEUTICAL ASSOCIATES, INC.]1
acesulfame potassiumINACTIVE INGREDIENT23OV73Q5G9CHILDRENS ACETAMINOPHEN (ACETAMINOPHEN) SUSPENSION [PHARMACEUTICAL ASSOCIATES, INC.]1
ButylparabenINACTIVE INGREDIENT3QPI1U3FV8CHILDRENS ACETAMINOPHEN (ACETAMINOPHEN) SUSPENSION [PHARMACEUTICAL ASSOCIATES, INC.]1
Citric Acid MonohydrateINACTIVE INGREDIENT2968PHW8QPCHILDRENS ACETAMINOPHEN (ACETAMINOPHEN) SUSPENSION [PHARMACEUTICAL ASSOCIATES, INC.]1
corn syrupINACTIVE INGREDIENT9G5L16BK6NCHILDRENS ACETAMINOPHEN (ACETAMINOPHEN) SUSPENSION [PHARMACEUTICAL ASSOCIATES, INC.]1
FD&C Red No. 40INACTIVE INGREDIENTWZB9127XOACHILDRENS ACETAMINOPHEN (ACETAMINOPHEN) SUSPENSION [PHARMACEUTICAL ASSOCIATES, INC.]1
glycerinINACTIVE INGREDIENTPDC6A3C0OXCHILDRENS ACETAMINOPHEN (ACETAMINOPHEN) SUSPENSION [PHARMACEUTICAL ASSOCIATES, INC.]1
Magnesium Aluminum SilicateINACTIVE INGREDIENT6M3P64V0NCCHILDRENS ACETAMINOPHEN (ACETAMINOPHEN) SUSPENSION [PHARMACEUTICAL ASSOCIATES, INC.]1
Polysorbate 80INACTIVE INGREDIENT6OZP39ZG8HCHILDRENS ACETAMINOPHEN (ACETAMINOPHEN) SUSPENSION [PHARMACEUTICAL ASSOCIATES, INC.]1
Propylene GlycolINACTIVE INGREDIENT6DC9Q167V3CHILDRENS ACETAMINOPHEN (ACETAMINOPHEN) SUSPENSION [PHARMACEUTICAL ASSOCIATES, INC.]1
Sodium BenzoateINACTIVE INGREDIENTOJ245FE5EUCHILDRENS ACETAMINOPHEN (ACETAMINOPHEN) SUSPENSION [PHARMACEUTICAL ASSOCIATES, INC.]1
sorbitolINACTIVE INGREDIENT506T60A25RCHILDRENS ACETAMINOPHEN (ACETAMINOPHEN) SUSPENSION [PHARMACEUTICAL ASSOCIATES, INC.]1
WaterINACTIVE INGREDIENT059QF0KO0RCHILDRENS ACETAMINOPHEN (ACETAMINOPHEN) SUSPENSION [PHARMACEUTICAL ASSOCIATES, INC.]1
Xanthan GumINACTIVE INGREDIENTTTV12P4NEECHILDRENS ACETAMINOPHEN (ACETAMINOPHEN) SUSPENSION [PHARMACEUTICAL ASSOCIATES, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0121-1781CHILDRENS ACETAMINOPHEN (ACETAMINOPHEN) SUSPENSION [PAI HOLDINGS, LLC DBA PAI PHARMA]13Current NDC, Legacy NDC, 3 package rows20241010_46d9d8cd-e3db-492c-9386-7e8255beff64.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 8 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AspirinASPIRINUnited Natural Foods, Inc. dba UNFI19c7f832-d7ec-4dcc-8aa4-f4cbf64c9ff62026-07-02WarningsExact identifier
application number: M013
pain relief EXTRA STRENGTHACETAMINOPHENMeijer Distribution, Inc.ae84eb7e-a70b-4311-b2dc-ad153047a5162026-07-01WarningsExact identifier
application number: M013
Aspirin 325 mgASPIRINHi-Tech Nutraceuticals, LLCb3426a9a-ea99-da30-e053-2995a90a1e4b2026-07-01WarningsExact identifier
application number: M013
Headache Relief Extra StrengthACETAMINOPHEN, ASPIRIN AND CAFFEINESalado Sales, Inc.ca21d576-be3c-495d-9dbd-ed514bf65da72026-07-01WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENMeijer Distribution Inc4e08a7cb-3894-84c3-e063-6394a90a0b422026-06-30WarningsExact identifier
application number: M013
Headache Relief Extra StrengthACETAMINOPHEN, ASPIRIN AND CAFFEINEWal-Mart Stores Inc9b1201af-c802-4e19-b192-bbbf34367db42026-06-30WarningsExact identifier
application number: M013
Pain RelieverACETAMINOPHENP & L Development, LLCfc841cba-8f4f-407b-97de-0422977515bd2026-06-30WarningsExact identifier
application number: M013
Headache ReliefACETAMINOPHEN, ASPIRIN, CAFFEINEUnited Natural Foods, Inc. dba UNFIb6ff2b34-51ee-41bc-8b7d-7520ade0bf362026-06-30WarningsExact identifier
application number: M013
MedlineASPIRINMedline Industries, LP4b0c569a-ed7a-e104-e063-6394a90a6d542026-06-29WarningsExact identifier
application number: M013
Pain Reliever PMACETAMINOPHEN, DIPHENHYDRAMINE HCLWALMART INC.e50b3f60-b827-426c-8e78-8447c89130fe2026-06-29WarningsExact identifier
application number: M013
Acetaminophen PMACETAMINOPHEN, DIPHENHYDRAMINE HCLChain Drug Marketing Association, Inc.e58417f4-3575-4433-ac2e-b7bf9fe8ba102026-06-29WarningsExact identifier
application number: M013
Dr Kids Pain and FeverACETAMINOPHENCalmCo LLC5534a784-a7b1-5599-e063-6294a90a79612026-06-27WarningsExact identifier
application number: M013
TYLENOL Extra StrengthACETAMINOPHENSelect Consumer Group LLC529d3a51-a248-7c02-e063-6294a90a10ae2026-06-27WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENSportpharm LLC830ffcaa-7ff8-4732-bc84-6a8c5e78722d2026-06-25WarningsExact identifier
application number: M013
AspirinASPIRINStrategic Sourcing Services LLCea2ef485-429e-4c63-ba7b-0a6b32892ad22026-06-25WarningsExact identifier
application number: M013
AspirinASPIRINChain Drug Marketing Association, Inc.055d8420-c189-4a9e-acdc-21627935c8eb2026-06-25WarningsExact identifier
application number: M013
AspirinASPIRINTopco Associates, LLC5f32cf74-dbea-496c-ba23-2040ea354f402026-06-25WarningsExact identifier
application number: M013
AspirinASPIRINSalado Sales, Inc.cf3139a5-e36e-48e3-bb6c-e102b0cec5552026-06-25WarningsExact identifier
application number: M013
Pain Relief AspirinASPIRINRite Aid Corporationbd69d3d2-5d38-47c6-98a6-124f7a43b8b02026-06-25WarningsExact identifier
application number: M013
Aspirin Regular StrengthASPIRINWalgreen Company0b27c0fd-7ea8-4588-9169-5ad4e8df77ef2026-06-25WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
307668acetaminophen 160 MG in 5 mL Oral SuspensionPSN38b839b6-de7d-4f33-a19a-efc92cdad92c16
307668acetaminophen 32 MG/ML Oral SuspensionSCD38b839b6-de7d-4f33-a19a-efc92cdad92c16
307668acetaminophen 160 MG per 5 ML Oral SuspensionSY38b839b6-de7d-4f33-a19a-efc92cdad92c16
307668acetaminophen 320 MG per 10 ML Oral SuspensionSY38b839b6-de7d-4f33-a19a-efc92cdad92c16
307668acetaminophen 650 MG per 20.3 ML Oral SuspensionSY38b839b6-de7d-4f33-a19a-efc92cdad92c16
307668acetaminophen 80 MG per 2.5 ML Oral SuspensionSY38b839b6-de7d-4f33-a19a-efc92cdad92c16
307668APAP 32 MG/ML Oral SuspensionSY38b839b6-de7d-4f33-a19a-efc92cdad92c16
307668acetaminophen 160 MG in 5 mL Oral SuspensionPSN46d9d8cd-e3db-492c-9386-7e8255beff6413
307668acetaminophen 32 MG/ML Oral SuspensionSCD46d9d8cd-e3db-492c-9386-7e8255beff6413
307668acetaminophen 160 MG per 5 ML Oral SuspensionSY46d9d8cd-e3db-492c-9386-7e8255beff6413
307668acetaminophen 320 MG per 10 ML Oral SuspensionSY46d9d8cd-e3db-492c-9386-7e8255beff6413
307668acetaminophen 650 MG per 20.3 ML Oral SuspensionSY46d9d8cd-e3db-492c-9386-7e8255beff6413
307668acetaminophen 80 MG per 2.5 ML Oral SuspensionSY46d9d8cd-e3db-492c-9386-7e8255beff6413
307668APAP 32 MG/ML Oral SuspensionSY46d9d8cd-e3db-492c-9386-7e8255beff6413
307668acetaminophen 160 MG in 5 mL Oral SuspensionPSN7562f4e4-54fa-488c-a199-48ad2632e2a19
307668acetaminophen 32 MG/ML Oral SuspensionSCD7562f4e4-54fa-488c-a199-48ad2632e2a19
307668acetaminophen 160 MG per 5 ML Oral SuspensionSY7562f4e4-54fa-488c-a199-48ad2632e2a19
307668acetaminophen 320 MG per 10 ML Oral SuspensionSY7562f4e4-54fa-488c-a199-48ad2632e2a19
307668acetaminophen 650 MG per 20.3 ML Oral SuspensionSY7562f4e4-54fa-488c-a199-48ad2632e2a19
307668acetaminophen 80 MG per 2.5 ML Oral SuspensionSY7562f4e4-54fa-488c-a199-48ad2632e2a19
307668APAP 32 MG/ML Oral SuspensionSY7562f4e4-54fa-488c-a199-48ad2632e2a19

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0121-1781-000012117810010 TRAY in 1 CASE (0121-1781-00) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0121-1781-05) 10 tray2007-09-170000-00-00NoNoCurrent
0121-1781-05001211781055 mL in 1 CUP, UNIT-DOSE5 mlHistorical