ACETAMINOPHEN

Product NDC: 17856-5401
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 · 10 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	17856-5401		I	Inactivated by FDA	2026-10-15
excluded package	package	17856-5401	17856-5401-1	I	Inactivated by FDA	2026-10-15
excluded package	package	17856-5401	17856-5401-2	I	Inactivated by FDA	2026-10-15
excluded package	package	17856-5401	17856-5401-3	I	Inactivated by FDA	2026-10-15
excluded package	package	17856-5401	17856-5401-4	I	Inactivated by FDA	2026-10-15
excluded package	package	17856-5401	17856-5401-5	I	Inactivated by FDA	2026-10-15
excluded package	package	17856-5401	17856-5401-6	I	Inactivated by FDA	2026-10-15
excluded package	package	17856-5401	17856-5401-7	I	Inactivated by FDA	2026-10-15
excluded package	package	17856-5401	17856-5401-8	I	Inactivated by FDA	2026-10-15
excluded package	package	17856-5401	17856-5401-9	I	Inactivated by FDA	2026-10-15

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 3 · 180 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	17856-5401-6	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	17856-5401-1	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	17856-5401-7	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	17856-5401-2	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	17856-5401-5	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	17856-5401-4	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	17856-5401-9	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	17856-5401-3	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	17856-5401-8	`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	17856-5401-6	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	17856-5401-1	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	17856-5401-7	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	17856-5401-2	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	17856-5401-5	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	17856-5401-4	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	17856-5401-9	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	17856-5401-3	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	17856-5401-8	`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	17856-5401-6	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	17856-5401-1	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	17856-5401-7	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	17856-5401-2	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	17856-5401-5	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	17856-5401-4	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	17856-5401-9	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	17856-5401-3	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	17856-5401-8	`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	17856-5401-6	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	17856-5401-1	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	17856-5401-7	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	17856-5401-2	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	17856-5401-5	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	17856-5401-4	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	17856-5401-9	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	17856-5401-3	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	17856-5401-8	`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	17856-5401-6	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	17856-5401-1	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	17856-5401-7	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	17856-5401-2	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	17856-5401-5	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	17856-5401-4	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	17856-5401-9	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	17856-5401-3	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	17856-5401-8	`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	17856-5401-6	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	17856-5401-1	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	17856-5401-7	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	17856-5401-2	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	17856-5401-5	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	17856-5401-4	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	17856-5401-9	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	17856-5401-3	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	17856-5401-8	`cdf11ea48f46…`	`ba0047e9e063…`

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
17856-5401-1	ACETAMINOPHEN	1.5 mL in 1 SYRINGE	ELIXIR	1.5	1
17856-5401-1	ACETAMINOPHEN	120 in 1 BOX, UNIT-DOSE	ELIXIR	120	1
17856-5401-2	ACETAMINOPHEN	120 in 1 BOX, UNIT-DOSE	ELIXIR	120	1
17856-5401-2	ACETAMINOPHEN	2 mL in 1 SYRINGE	ELIXIR	2	1
17856-5401-3	ACETAMINOPHEN	3 mL in 1 SYRINGE	ELIXIR	3	1
17856-5401-3	ACETAMINOPHEN	120 in 1 BOX, UNIT-DOSE	ELIXIR	120	1
17856-5401-4	ACETAMINOPHEN	48 in 1 BOX, UNIT-DOSE	ELIXIR	48	1
17856-5401-4	ACETAMINOPHEN	3.75 mL in 1 SYRINGE	ELIXIR	3.75	1
17856-5401-5	ACETAMINOPHEN	72 in 1 BOX, UNIT-DOSE	ELIXIR	72	1
17856-5401-5	ACETAMINOPHEN	5 mL in 1 CUP, UNIT-DOSE	ELIXIR	5	1
17856-5401-6	ACETAMINOPHEN	6 mL in 1 SYRINGE	ELIXIR	6	1
17856-5401-6	ACETAMINOPHEN	48 in 1 BOX, UNIT-DOSE	ELIXIR	48	1
17856-5401-7	ACETAMINOPHEN	7.5 mL in 1 SYRINGE	ELIXIR	7.5	1
17856-5401-7	ACETAMINOPHEN	48 in 1 BOX, UNIT-DOSE	ELIXIR	48	1
17856-5401-8	ACETAMINOPHEN	10.15 mL in 1 CUP, UNIT-DOSE	ELIXIR	10.15	1
17856-5401-8	ACETAMINOPHEN	72 in 1 BOX, UNIT-DOSE	ELIXIR	72	1
17856-5401-9	ACETAMINOPHEN	15 mL in 1 CUP, UNIT-DOSE	ELIXIR	15	1
17856-5401-9	ACETAMINOPHEN	50 in 1 BOX, UNIT-DOSE	ELIXIR	50	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
17856-5401	ACETAMINOPHEN ELIXIR [ATLANTIC BIOLOGICALS CORP.]	1	Legacy NDC, 18 package rows	20200903_e040616b-bdca-4f5d-9d43-6dc64dc425f1.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	e040616b-bdca-4f5d-9d43-6dc64dc425f1	1
307675	acetaminophen 32 MG/ML Oral Solution	SCD	e040616b-bdca-4f5d-9d43-6dc64dc425f1	1
307675	acetaminophen 160 MG per 5 ML Oral Solution	SY	e040616b-bdca-4f5d-9d43-6dc64dc425f1	1
307675	acetaminophen 325 MG per 10.15 ML Oral Solution	SY	e040616b-bdca-4f5d-9d43-6dc64dc425f1	1
307675	acetaminophen 650 MG per 20.3 ML Oral Solution	SY	e040616b-bdca-4f5d-9d43-6dc64dc425f1	1
307675	acetaminophen 80 MG per 2.5 ML Oral Solution	SY	e040616b-bdca-4f5d-9d43-6dc64dc425f1	1
307675	APAP 32 MG/ML Oral Solution	SY	e040616b-bdca-4f5d-9d43-6dc64dc425f1	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
17856-5401-1	17856540101	120 SYRINGE in 1 BOX, UNIT-DOSE (17856-5401-1) > 1.5 mL in 1 SYRINGE	120 syringe	2020-09-02	0000-00-00	No	No	Current
17856-5401-2	17856540102	120 SYRINGE in 1 BOX, UNIT-DOSE (17856-5401-2) > 2 mL in 1 SYRINGE	120 syringe	2020-09-02	0000-00-00	No	No	Current
17856-5401-3	17856540103	120 SYRINGE in 1 BOX, UNIT-DOSE (17856-5401-3) > 3 mL in 1 SYRINGE	120 syringe	2020-09-02	0000-00-00	No	No	Current
17856-5401-4	17856540104	48 SYRINGE in 1 BOX, UNIT-DOSE (17856-5401-4) > 3.75 mL in 1 SYRINGE	48 syringe	2020-09-02	0000-00-00	No	No	Current
17856-5401-5	17856540105	72 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-5401-5) > 5 mL in 1 CUP, UNIT-DOSE		2020-09-02	0000-00-00	No	No	Current
17856-5401-6	17856540106	48 SYRINGE in 1 BOX, UNIT-DOSE (17856-5401-6) > 6 mL in 1 SYRINGE	48 syringe	2020-09-02	0000-00-00	No	No	Current
17856-5401-7	17856540107	48 SYRINGE in 1 BOX, UNIT-DOSE (17856-5401-7) > 7.5 mL in 1 SYRINGE	48 syringe	2020-09-02	0000-00-00	No	No	Current
17856-5401-8	17856540108	72 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-5401-8) > 10.15 mL in 1 CUP, UNIT-DOSE		2020-09-02	0000-00-00	No	No	Current
17856-5401-9	17856540109	50 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-5401-9) > 15 mL in 1 CUP, UNIT-DOSE		2020-09-02	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Children’s Pain Relief Grape Flavor Pain Reliever and Fever Reducer	ATLANTIC BIOLOGICALS CORP.	2020-09-02	HUMAN OTC DRUG LABEL	1