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

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 Identifiers#

Field, Values table
FieldValues
Unii362O9ITL9D
Rxcui307668

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-dadaa90a57ceb8922e83-337b-45c0-ae4f-ff6e111546cb

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 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

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