FDA.reportPublic FDA data

ACETAMINOPHEN

Product NDC
17856-5401
Requested package NDC
17856-5401-8
11-digit product format
178565401
Labeler code
17856
Product ID
17856-5401_b17d8b01-e4bf-4730-b154-c7c0d363e95a
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
ELIXIR
Route
ORAL
Labeler
ATLANTIC BIOLOGICALS CORP.
Application
part343
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2020-07-28
Marketing end
0000-00-00
Substance
ACETAMINOPHEN
Active strength
160 mg/5mL
NDC exclude flag
No
Listing certified through
2021-12-31
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 packagepackage17856-540117856-5401-8IInactivated by FDA2026-10-15

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 · 18 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…
2022-08-30 03:57 UTC · source 2022-08-29fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-0886f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01bd6a592717d7…303034d00443…

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
17856-5401-1Children’s Pain Relief Grape Flavor Pain Reliever and Fever Reducer
17856-5401-2Children’s Pain Relief Grape Flavor Pain Reliever and Fever Reducer
17856-5401-3Children’s Pain Relief Grape Flavor Pain Reliever and Fever Reducer
17856-5401-4Children’s Pain Relief Grape Flavor Pain Reliever and Fever Reducer
17856-5401-5Children’s Pain Relief Grape Flavor Pain Reliever and Fever Reducer
17856-5401-6Children’s Pain Relief Grape Flavor Pain Reliever and Fever Reducer
17856-5401-7Children’s Pain Relief Grape Flavor Pain Reliever and Fever Reducer
17856-5401-8Children’s Pain Relief Grape Flavor Pain Reliever and Fever Reducer
17856-5401-9Children’s Pain Relief Grape Flavor Pain Reliever and Fever Reducer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17856-5401-1ACETAMINOPHEN1.5 mL in 1 SYRINGEELIXIR1.51
17856-5401-1ACETAMINOPHEN120 in 1 BOX, UNIT-DOSEELIXIR1201
17856-5401-2ACETAMINOPHEN120 in 1 BOX, UNIT-DOSEELIXIR1201
17856-5401-2ACETAMINOPHEN2 mL in 1 SYRINGEELIXIR21
17856-5401-3ACETAMINOPHEN3 mL in 1 SYRINGEELIXIR31
17856-5401-3ACETAMINOPHEN120 in 1 BOX, UNIT-DOSEELIXIR1201
17856-5401-4ACETAMINOPHEN48 in 1 BOX, UNIT-DOSEELIXIR481
17856-5401-4ACETAMINOPHEN3.75 mL in 1 SYRINGEELIXIR3.751
17856-5401-5ACETAMINOPHEN72 in 1 BOX, UNIT-DOSEELIXIR721
17856-5401-5ACETAMINOPHEN5 mL in 1 CUP, UNIT-DOSEELIXIR51
17856-5401-6ACETAMINOPHEN6 mL in 1 SYRINGEELIXIR61
17856-5401-6ACETAMINOPHEN48 in 1 BOX, UNIT-DOSEELIXIR481
17856-5401-7ACETAMINOPHEN7.5 mL in 1 SYRINGEELIXIR7.51
17856-5401-7ACETAMINOPHEN48 in 1 BOX, UNIT-DOSEELIXIR481
17856-5401-8ACETAMINOPHEN10.15 mL in 1 CUP, UNIT-DOSEELIXIR10.151
17856-5401-8ACETAMINOPHEN72 in 1 BOX, UNIT-DOSEELIXIR721
17856-5401-9ACETAMINOPHEN15 mL in 1 CUP, UNIT-DOSEELIXIR151
17856-5401-9ACETAMINOPHEN50 in 1 BOX, UNIT-DOSEELIXIR501

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17856-5401ACETAMINOPHEN ELIXIR [ATLANTIC BIOLOGICALS CORP.]1Legacy NDC, 18 package rows20200903_e040616b-bdca-4f5d-9d43-6dc64dc425f1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
307675acetaminophen 160 MG in 5 mL Oral SolutionPSNe040616b-bdca-4f5d-9d43-6dc64dc425f11
307675acetaminophen 32 MG/ML Oral SolutionSCDe040616b-bdca-4f5d-9d43-6dc64dc425f11
307675acetaminophen 160 MG per 5 ML Oral SolutionSYe040616b-bdca-4f5d-9d43-6dc64dc425f11
307675acetaminophen 325 MG per 10.15 ML Oral SolutionSYe040616b-bdca-4f5d-9d43-6dc64dc425f11
307675acetaminophen 650 MG per 20.3 ML Oral SolutionSYe040616b-bdca-4f5d-9d43-6dc64dc425f11
307675acetaminophen 80 MG per 2.5 ML Oral SolutionSYe040616b-bdca-4f5d-9d43-6dc64dc425f11
307675APAP 32 MG/ML Oral SolutionSYe040616b-bdca-4f5d-9d43-6dc64dc425f11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
17856-5401-81785654010872 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-5401-8) > 10.15 mL in 1 CUP, UNIT-DOSE2020-09-020000-00-00NoNoCurrent