ACETAMINOPHEN

Product NDC: 17856-0179
11-digit product format: 178560179
Labeler code: 17856
Product ID: 17856-0179_b9868329-402b-438b-b80c-eeee223fe3af
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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	17856-0179		I	Inactivated by FDA	2026-10-20
excluded package	package	17856-0179	17856-0179-3	I	Inactivated by FDA	2026-10-20
excluded package	package	17856-0179	17856-0179-6	I	Inactivated by FDA	2026-10-20
excluded package	package	17856-0179	17856-0179-9	I	Inactivated by FDA	2026-10-20

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 · 60 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	17856-0179-3	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	17856-0179-6	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	17856-0179-9	`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	17856-0179-3	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	17856-0179-6	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	17856-0179-9	`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	17856-0179-3	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	17856-0179-6	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	17856-0179-9	`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	17856-0179-3	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	17856-0179-6	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	17856-0179-9	`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	17856-0179-3	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	17856-0179-6	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	17856-0179-9	`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	17856-0179-3	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	17856-0179-6	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	17856-0179-9	`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	17856-0179-3	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	17856-0179-6	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	17856-0179-9	`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	17856-0179-3	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	17856-0179-6	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	17856-0179-9	`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	17856-0179-3	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	17856-0179-6	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	17856-0179-9	`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	17856-0179-3	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	17856-0179-6	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	17856-0179-9	`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	17856-0179-3	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	17856-0179-6	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	17856-0179-9	`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	17856-0179-3	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	17856-0179-6	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	17856-0179-9	`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	17856-0179-3	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	17856-0179-6	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	17856-0179-9	`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	17856-0179-3	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	17856-0179-6	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	17856-0179-9	`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	17856-0179-3	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	17856-0179-6	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	17856-0179-9	`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
17856-0179-3	2024-01-30	C162847	48780-1	1030e364-fae1-111a-e063-dadaa90a10e2	Acetaminophen Elxir Bubble Gum Flavor
17856-0179-6	2024-01-30	C162847	48780-1	1030e364-fae1-111a-e063-dadaa90a10e2	Acetaminophen Elxir Bubble Gum Flavor
17856-0179-9	2024-01-30	C162847	48780-1	1030e364-fae1-111a-e063-dadaa90a10e2	Acetaminophen Elxir Bubble Gum Flavor

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
17856-0179-1	ACETAMINOPHEN	48 in 1 BOX, UNIT-DOSE	ELIXIR	48	1
17856-0179-2	ACETAMINOPHEN	5 mL in 1 SYRINGE	ELIXIR	5	1
17856-0179-3	ACETAMINOPHEN	5 in 1 SYRINGE	ELIXIR	5	1
17856-0179-4	ACETAMINOPHEN	48 in 1 BOX, UNIT-DOSE	ELIXIR	48	1
17856-0179-5	ACETAMINOPHEN	7.5 mL in 1 SYRINGE	ELIXIR	7.5	1
17856-0179-6	ACETAMINOPHEN	5 in 1 SYRINGE	ELIXIR	5	1
17856-0179-7	ACETAMINOPHEN	120 in 1 BOX, UNIT-DOSE	ELIXIR	120	1
17856-0179-8	ACETAMINOPHEN	1.25 mL in 1 SYRINGE	ELIXIR	1.25	1
17856-0179-9	ACETAMINOPHEN	5 in 1 SYRINGE	ELIXIR	5	1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
17856-0179-1	ML - Milliliter	17856-0179	016a4150-0fa1-44fc-811f-8e76dd7a094f	1	2023-06-06
17856-0179-4	ML - Milliliter	17856-0179	59723d69-8069-4855-922c-64cbc76e8023	1	2023-06-06
17856-0179-7	ML - Milliliter	17856-0179	765521b9-9146-42e4-9a09-51baa575ce31	1	2023-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
17856-0179	ACETAMINOPHEN ELIXIR [ATLANTIC BIOLOGICALS CORP.]	1	Legacy NDC, 9 package rows	20221104_aa1c0232-c806-4674-9ac3-6cae7f7499b4.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	aa1c0232-c806-4674-9ac3-6cae7f7499b4	1
307675	acetaminophen 32 MG/ML Oral Solution	SCD	aa1c0232-c806-4674-9ac3-6cae7f7499b4	1
307675	acetaminophen 160 MG per 5 ML Oral Solution	SY	aa1c0232-c806-4674-9ac3-6cae7f7499b4	1
307675	acetaminophen 325 MG per 10.15 ML Oral Solution	SY	aa1c0232-c806-4674-9ac3-6cae7f7499b4	1
307675	acetaminophen 650 MG per 20.3 ML Oral Solution	SY	aa1c0232-c806-4674-9ac3-6cae7f7499b4	1
307675	acetaminophen 80 MG per 2.5 ML Oral Solution	SY	aa1c0232-c806-4674-9ac3-6cae7f7499b4	1
307675	APAP 32 MG/ML Oral Solution	SY	aa1c0232-c806-4674-9ac3-6cae7f7499b4	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
17856-0179-1	17856017901	48 in 1 BOX, UNIT-DOSE						Historical
17856-0179-2	17856017902	5 mL in 1 SYRINGE	5 ml					Historical
17856-0179-3	17856017903	5 BOX, UNIT-DOSE in 1 SYRINGE (17856-0179-3) > 48 SYRINGE in 1 BOX, UNIT-DOSE (17856-0179-1) > 5 mL in 1 SYRINGE (17856-0179-2)		2022-11-03	0000-00-00	No	No	Current
17856-0179-4	17856017904	48 in 1 BOX, UNIT-DOSE						Historical
17856-0179-5	17856017905	7.5 mL in 1 SYRINGE	7.5 ml					Historical
17856-0179-6	17856017906	5 BOX, UNIT-DOSE in 1 SYRINGE (17856-0179-6) > 48 SYRINGE in 1 BOX, UNIT-DOSE (17856-0179-4) > 7.5 mL in 1 SYRINGE (17856-0179-5)		2022-11-03	0000-00-00	No	No	Current
17856-0179-7	17856017907	120 in 1 BOX, UNIT-DOSE						Historical
17856-0179-8	17856017908	1.25 mL in 1 SYRINGE	1.25 ml					Historical
17856-0179-9	17856017909	5 BOX, UNIT-DOSE in 1 SYRINGE (17856-0179-9) > 120 SYRINGE in 1 BOX, UNIT-DOSE (17856-0179-7) > 1.25 mL in 1 SYRINGE (17856-0179-8)		2022-11-03	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Acetaminophen Elxir Bubble Gum Flavor	ATLANTIC BIOLOGICALS CORP. \| UNIT DOSE SOLUTIONS	2022-10-25	HUMAN OTC DRUG LABEL	1