ACETAMINOPHEN

Product NDC: 17856-0182
11-digit product format: 178560182
Labeler code: 17856
Product ID: 17856-0182_d19a5550-893e-414a-b725-f326cfd635cc
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: 2021-05-18
Marketing end: 0000-00-00
Substance: ACETAMINOPHEN
Active strength: 160 mg/5mL
NDC exclude flag: No
Listing certified through: 2023-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	17856-0182		I	Inactivated by FDA	2026-10-05
excluded package	package	17856-0182	17856-0182-3	I	Inactivated by FDA	2026-10-05
excluded package	package	17856-0182	17856-0182-4	I	Inactivated by FDA	2026-10-05

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 · 45 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	17856-0182-4	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	17856-0182-3	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	17856-0182-4	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	17856-0182-3	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	17856-0182-4	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	17856-0182-3	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	17856-0182-4	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	17856-0182-3	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	17856-0182-4	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	17856-0182-3	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	17856-0182-4	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	17856-0182-3	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	17856-0182-4	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	17856-0182-3	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	17856-0182-4	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	17856-0182-3	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	17856-0182-4	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	17856-0182-3	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	17856-0182-4	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	17856-0182-3	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	17856-0182-4	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	17856-0182-3	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	17856-0182-4	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	17856-0182-3	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	17856-0182-4	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	17856-0182-3	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	17856-0182-4	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	17856-0182-3	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	17856-0182-4	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	17856-0182-3	`1332a3947898…`	`d4bfe170f9cd…`

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
17856-0182-3	2024-01-30	C162847	48780-1	1030e364-fb3f-111a-e063-dadaa90a10e2	Acetaminophen Elxir Bubble Gum Flavor
17856-0182-4	2024-01-30	C162847	48780-1	1030e364-fb3f-111a-e063-dadaa90a10e2	Acetaminophen Elxir Bubble Gum Flavor

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
17856-0182-1	ACETAMINOPHEN	120 in 1 BOX, UNIT-DOSE	ELIXIR	120	3
17856-0182-2	ACETAMINOPHEN	2 mL in 1 SYRINGE	ELIXIR	2	3
17856-0182-3	ACETAMINOPHEN	5 in 1 SYRINGE	ELIXIR	5	3
17856-0182-4	ACETAMINOPHEN	72 in 1 BOX, UNIT-DOSE	ELIXIR	72	3
17856-0182-5	ACETAMINOPHEN	5 mL in 1 CUP, UNIT-DOSE	ELIXIR	5	3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
17856-0182-4	ML - Milliliter	17856-0182	095990e2-50ba-4bb4-a465-af7821d7ccb3	1	2023-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
17856-0182	ACETAMINOPHEN ELIXIR [ATLANTIC BIOLOGICALS CORP.]	3	Legacy NDC, 5 package rows	20221115_cf2dd95d-afea-462d-9dba-a46a68bf67e6.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
362O9ITL9D	ACETAMINOPHEN	103-90-2	ACETAMINOPHEN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
307675	acetaminophen 160 MG in 5 mL Oral Solution	PSN	cf2dd95d-afea-462d-9dba-a46a68bf67e6	3
307675	acetaminophen 32 MG/ML Oral Solution	SCD	cf2dd95d-afea-462d-9dba-a46a68bf67e6	3
307675	acetaminophen 160 MG per 5 ML Oral Solution	SY	cf2dd95d-afea-462d-9dba-a46a68bf67e6	3
307675	acetaminophen 325 MG per 10.15 ML Oral Solution	SY	cf2dd95d-afea-462d-9dba-a46a68bf67e6	3
307675	acetaminophen 650 MG per 20.3 ML Oral Solution	SY	cf2dd95d-afea-462d-9dba-a46a68bf67e6	3
307675	acetaminophen 80 MG per 2.5 ML Oral Solution	SY	cf2dd95d-afea-462d-9dba-a46a68bf67e6	3
307675	APAP 32 MG/ML Oral Solution	SY	cf2dd95d-afea-462d-9dba-a46a68bf67e6	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
17856-0182-1	17856018201	120 in 1 BOX, UNIT-DOSE						Historical
17856-0182-2	17856018202	2 mL in 1 SYRINGE	2 ml					Historical
17856-0182-3	17856018203	5 BOX, UNIT-DOSE in 1 SYRINGE (17856-0182-3) > 120 SYRINGE in 1 BOX, UNIT-DOSE (17856-0182-1) > 2 mL in 1 SYRINGE (17856-0182-2)		2022-11-03	0000-00-00	No	No	Current
17856-0182-4	17856018204	72 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-0182-4) > 5 mL in 1 CUP, UNIT-DOSE (17856-0182-5)		2022-11-14	0000-00-00	No	No	Current
17856-0182-5	17856018205	5 mL in 1 CUP, UNIT-DOSE	5 ml					Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Acetaminophen Elxir Bubble Gum Flavor	ATLANTIC BIOLOGICALS CORP. \| UNIT DOSE SOLUTIONS	2022-11-14	HUMAN OTC DRUG LABEL	3