FDA.reportPublic FDA data

Childrens Acetaminophen

Product NDC
17856-0201
Requested package NDC
17856-0201-5
11-digit product format
178560201
Labeler code
17856
Product ID
17856-0201_b15d23d6-408c-45e3-a59d-385c6e9ab25b
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
SUSPENSION
Route
ORAL
Labeler
ATLANTIC BIOLOGICALS CORP.
Application
part343
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2014-04-09
Marketing end
0000-00-00
Substance
ACETAMINOPHEN
Active strength
160 mg/5mL
NDC exclude flag
No
Listing certified through
2022-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage17856-020117856-0201-5IInactivated by FDA2026-10-05

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 · 15 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDCRelated label
17856-0201-1Perrigo Children’s Acetaminophen Drug Facts
17856-0201-2Perrigo Children’s Acetaminophen Drug Facts
17856-0201-3Perrigo Children’s Acetaminophen Drug Facts
17856-0201-4Perrigo Children’s Acetaminophen Drug Facts
17856-0201-5Perrigo Children’s Acetaminophen Drug Facts
17856-0201-6Perrigo Children’s Acetaminophen Drug Facts
17856-0201-7Perrigo Children’s Acetaminophen Drug Facts
17856-0201-8Perrigo Children’s Acetaminophen Drug Facts
17856-0201-9Perrigo Children’s Acetaminophen Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17856-0201-1Childrens Acetaminophen2.5 mL in 1 SYRINGESUSPENSION2.52
17856-0201-1Childrens Acetaminophen120 in 1 BOX, UNIT-DOSESUSPENSION1202
17856-0201-2Childrens Acetaminophen120 in 1 BOX, UNIT-DOSESUSPENSION1202
17856-0201-2Childrens Acetaminophen1.25 mL in 1 SYRINGESUSPENSION1.252
17856-0201-3Childrens Acetaminophen5 mL in 1 SYRINGESUSPENSION52
17856-0201-3Childrens Acetaminophen48 in 1 BOX, UNIT-DOSESUSPENSION482
17856-0201-4Childrens Acetaminophen5 mL in 1 CUP, UNIT-DOSESUSPENSION52
17856-0201-4Childrens Acetaminophen72 in 1 BOX, UNIT-DOSESUSPENSION722
17856-0201-5Childrens Acetaminophen60 in 1 BOX, UNIT-DOSESUSPENSION602
17856-0201-5Childrens Acetaminophen2.5 mL in 1 SYRINGESUSPENSION2.52
17856-0201-6Childrens Acetaminophen48 in 1 BOX, UNIT-DOSESUSPENSION482
17856-0201-6Childrens Acetaminophen7.5 mL in 1 SYRINGESUSPENSION7.52
17856-0201-7Childrens Acetaminophen15 mL in 1 CUP, UNIT-DOSESUSPENSION152
17856-0201-7Childrens Acetaminophen72 in 1 BOX, UNIT-DOSESUSPENSION722
17856-0201-8Childrens Acetaminophen2 mL in 1 SYRINGESUSPENSION22
17856-0201-8Childrens Acetaminophen120 in 1 BOX, UNIT-DOSESUSPENSION1202
17856-0201-9Childrens Acetaminophen120 in 1 BOX, UNIT-DOSESUSPENSION1202
17856-0201-9Childrens Acetaminophen2.5 mL in 1 SYRINGESUSPENSION2.52

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17856-0201CHILDRENS ACETAMINOPHEN (ACETAMINOPHEN) SUSPENSION [ATLANTIC BIOLOGICALS CORP.]2Legacy NDC, 18 package rows20211030_cc2f53bb-28cf-4a2f-b8b2-0c64fd274434.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
17856-0201-51785602010560 SYRINGE in 1 BOX, UNIT-DOSE (17856-0201-5) > 2.5 mL in 1 SYRINGE60 syringe2021-10-110000-00-00NoNoCurrent