Childrens ACCUDIAL

Product NDC
45014-137
11-digit product format
450140137
Labeler code
45014
Product ID
45014-137_3614e44e-8510-4fd2-9762-741b9659323d
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
SUSPENSION
Route
ORAL
Labeler
Accudial Pharmaceutical, Inc.
Application
part343
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2012-04-25
Marketing end
0000-00-00
Substance
ACETAMINOPHEN
Active strength
160 mg/5mL
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct45014-137IInactivated by FDA2026-10-12
excluded packagepackage45014-13745014-137-04IInactivated by FDA2026-10-12

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 · 44 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage45014-137-04d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage45014-137-04f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage45014-137-042ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage45014-137-04a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage45014-137-04cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage45014-137-04cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage45014-137-04302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage45014-137-04ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage45014-137-040efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage45014-137-04ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage45014-137-04367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage45014-137-04557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage45014-137-048af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage45014-137-04834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage45014-137-041332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage45014-137-04fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage45014-137-0486f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage45014-137-04bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage45014-137-048dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage45014-137-04e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage45014-137-049bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproduct110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage45014-137-04110d247fa046…a55b01930146…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
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
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
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
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
45014-137-042019-11-13C16284748780-197449f38-b978-f6ea-e053-dbdaa90aa703Children's ACCUDIAL ® Pain reliever/ Fever reducer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
45014-137-04Childrens ACCUDIAL Pain reliever/ Fever reducer118 mL in 1 BOTTLESUSPENSION1181

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AcetaminophenACTIVE INGREDIENT362O9ITL9DCHILDRENS ACCUDIAL PAIN RELIEVER/ FEVER REDUCER (ACETAMINOPHEN) SUSPENSION [ACCUDIAL PHARMACEUTICAL, INC.]1
AcetaminophenACTIVE MOIETY362O9ITL9DCHILDRENS ACCUDIAL PAIN RELIEVER/ FEVER REDUCER (ACETAMINOPHEN) SUSPENSION [ACCUDIAL PHARMACEUTICAL, INC.]1
Carboxymethylcellulose SodiumINACTIVE INGREDIENTK679OBS311CHILDRENS ACCUDIAL PAIN RELIEVER/ FEVER REDUCER (ACETAMINOPHEN) SUSPENSION [ACCUDIAL PHARMACEUTICAL, INC.]1
Cellulose, MicrocrystallineINACTIVE INGREDIENTOP1R32D61UCHILDRENS ACCUDIAL PAIN RELIEVER/ FEVER REDUCER (ACETAMINOPHEN) SUSPENSION [ACCUDIAL PHARMACEUTICAL, INC.]1
Citric Acid MonohydrateINACTIVE INGREDIENT2968PHW8QPCHILDRENS ACCUDIAL PAIN RELIEVER/ FEVER REDUCER (ACETAMINOPHEN) SUSPENSION [ACCUDIAL PHARMACEUTICAL, INC.]1
Corn SyrupINACTIVE INGREDIENT9G5L16BK6NCHILDRENS ACCUDIAL PAIN RELIEVER/ FEVER REDUCER (ACETAMINOPHEN) SUSPENSION [ACCUDIAL PHARMACEUTICAL, INC.]1
D&C red no. 33INACTIVE INGREDIENT9DBA0SBB0LCHILDRENS ACCUDIAL PAIN RELIEVER/ FEVER REDUCER (ACETAMINOPHEN) SUSPENSION [ACCUDIAL PHARMACEUTICAL, INC.]1
FD&C red no. 40INACTIVE INGREDIENTWZB9127XOACHILDRENS ACCUDIAL PAIN RELIEVER/ FEVER REDUCER (ACETAMINOPHEN) SUSPENSION [ACCUDIAL PHARMACEUTICAL, INC.]1
GlycerinINACTIVE INGREDIENTPDC6A3C0OXCHILDRENS ACCUDIAL PAIN RELIEVER/ FEVER REDUCER (ACETAMINOPHEN) SUSPENSION [ACCUDIAL PHARMACEUTICAL, INC.]1
Propylene GlycolINACTIVE INGREDIENT6DC9Q167V3CHILDRENS ACCUDIAL PAIN RELIEVER/ FEVER REDUCER (ACETAMINOPHEN) SUSPENSION [ACCUDIAL PHARMACEUTICAL, INC.]1
Sodium benzoateINACTIVE INGREDIENTOJ245FE5EUCHILDRENS ACCUDIAL PAIN RELIEVER/ FEVER REDUCER (ACETAMINOPHEN) SUSPENSION [ACCUDIAL PHARMACEUTICAL, INC.]1
SorbitolINACTIVE INGREDIENT506T60A25RCHILDRENS ACCUDIAL PAIN RELIEVER/ FEVER REDUCER (ACETAMINOPHEN) SUSPENSION [ACCUDIAL PHARMACEUTICAL, INC.]1
SucraloseINACTIVE INGREDIENT96K6UQ3ZD4CHILDRENS ACCUDIAL PAIN RELIEVER/ FEVER REDUCER (ACETAMINOPHEN) SUSPENSION [ACCUDIAL PHARMACEUTICAL, INC.]1
WaterINACTIVE INGREDIENT059QF0KO0RCHILDRENS ACCUDIAL PAIN RELIEVER/ FEVER REDUCER (ACETAMINOPHEN) SUSPENSION [ACCUDIAL PHARMACEUTICAL, INC.]1
Xanthan GumINACTIVE INGREDIENTTTV12P4NEECHILDRENS ACCUDIAL PAIN RELIEVER/ FEVER REDUCER (ACETAMINOPHEN) SUSPENSION [ACCUDIAL PHARMACEUTICAL, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45014-137CHILDRENS ACCUDIAL PAIN RELIEVER/ FEVER REDUCER (ACETAMINOPHEN) SUSPENSION [ACCUDIAL PHARMACEUTICAL, INC.]1Legacy NDC, 1 package rows20120517_00ab90e8-7824-411f-bf4d-a540c2a8a4c3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
307668acetaminophen 160 MG in 5 mL Oral SuspensionPSN00ab90e8-7824-411f-bf4d-a540c2a8a4c31
307668acetaminophen 32 MG/ML Oral SuspensionSCD00ab90e8-7824-411f-bf4d-a540c2a8a4c31
307668acetaminophen 160 MG per 5 ML Oral SuspensionSY00ab90e8-7824-411f-bf4d-a540c2a8a4c31
307668acetaminophen 320 MG per 10 ML Oral SuspensionSY00ab90e8-7824-411f-bf4d-a540c2a8a4c31
307668acetaminophen 650 MG per 20.3 ML Oral SuspensionSY00ab90e8-7824-411f-bf4d-a540c2a8a4c31
307668acetaminophen 80 MG per 2.5 ML Oral SuspensionSY00ab90e8-7824-411f-bf4d-a540c2a8a4c31
307668APAP 32 MG/ML Oral SuspensionSY00ab90e8-7824-411f-bf4d-a540c2a8a4c31

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
45014-137-0445014013704118 mL in 1 BOTTLE118 mlHistorical