Childrens Acetaminophen

Product NDC: 53807-129
11-digit product format: 538070129
Labeler code: 53807
Product ID: 53807-129_a332408b-6d43-4198-99a7-26c51dda1fcb
Type: HUMAN OTC DRUG
Nonproprietary name: Acetaminophen
Dosage form: ELIXIR
Route: ORAL
Labeler: Rij Pharmaceutical Corporation
Application: part343
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 1999-03-16
Marketing end: 0000-00-00
Substance: ACETAMINOPHEN
Active strength: 160 mg/5mL
NDC exclude flag: No
Listing certified through: 2019-12-31
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 · 7 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	53807-129		I	Inactivated by FDA	2026-10-05
excluded package	package	53807-129	53807-129-04	I	Inactivated by FDA	2026-10-05
excluded package	package	53807-129	53807-129-08	I	Inactivated by FDA	2026-10-05
excluded package	package	53807-129	53807-129-16	I	Inactivated by FDA	2026-10-05
excluded package	package	53807-129	53807-129-28	I	Inactivated by FDA	2026-10-05
excluded package	package	53807-129	53807-129-30	I	Inactivated by FDA	2026-10-05
excluded package	package	53807-129	53807-129-60	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 3 · 147 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	53807-129-04	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	53807-129-60	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	53807-129-16	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	53807-129-08	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	53807-129-28	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	53807-129-30	`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	53807-129-04	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	53807-129-60	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	53807-129-16	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	53807-129-08	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	53807-129-28	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	53807-129-30	`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	53807-129-04	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	53807-129-60	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	53807-129-16	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	53807-129-08	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	53807-129-28	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	53807-129-30	`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	53807-129-04	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	53807-129-60	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	53807-129-16	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	53807-129-08	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	53807-129-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	53807-129-30	`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	53807-129-04	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	53807-129-60	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	53807-129-16	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	53807-129-08	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	53807-129-28	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	53807-129-30	`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	53807-129-04	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	53807-129-60	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	53807-129-16	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	53807-129-08	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	53807-129-28	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	53807-129-30	`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	53807-129-04	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	53807-129-60	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	53807-129-16	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	53807-129-08	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	53807-129-28	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	53807-129-30	`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	53807-129-04	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	53807-129-60	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	53807-129-16	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	53807-129-08	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	53807-129-28	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	53807-129-30	`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	53807-129-04	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	53807-129-60	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	53807-129-16	`0efc9e666f02…`	`f202fb6c5f17…`

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
53807-129-04	CHILDRENS ACETAMINOPHEN
53807-129-08	CHILDRENS ACETAMINOPHEN
53807-129-16	CHILDRENS ACETAMINOPHEN
53807-129-28	CHILDRENS ACETAMINOPHEN
53807-129-30	CHILDRENS ACETAMINOPHEN
53807-129-60	CHILDRENS ACETAMINOPHEN

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
53807-129-04	Childrens Acetaminophen	118 mL in 1 BOTTLE	ELIXIR	118	2
53807-129-08	Childrens Acetaminophen	236 mL in 1 BOTTLE	ELIXIR	236	2
53807-129-16	Childrens Acetaminophen	473 mL in 1 BOTTLE	ELIXIR	473	2
53807-129-28	Childrens Acetaminophen	3785 mL in 1 BOTTLE	ELIXIR	3785	2
53807-129-30	Childrens Acetaminophen	30 mL in 1 BOTTLE	ELIXIR	30	2
53807-129-60	Childrens Acetaminophen	60 mL in 1 BOTTLE	ELIXIR	60	2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
53807-129-16	ML - Milliliter	53807-129	5436904d-855b-40ed-8306-e7fcfb1cd3b5	1	2013-05-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Acetaminophen	ACTIVE INGREDIENT	362O9ITL9D	CHILDRENS ACETAMINOPHEN (ACETAMINOPHEN) ELIXIR [RIJ PHARMACEUTICAL CORPORATION]	1
acetaminophen	ACTIVE MOIETY	362O9ITL9D	CHILDRENS ACETAMINOPHEN (ACETAMINOPHEN) ELIXIR [RIJ PHARMACEUTICAL CORPORATION]	1
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	CHILDRENS ACETAMINOPHEN (ACETAMINOPHEN) ELIXIR [RIJ PHARMACEUTICAL CORPORATION]	1
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	CHILDRENS ACETAMINOPHEN (ACETAMINOPHEN) ELIXIR [RIJ PHARMACEUTICAL CORPORATION]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	CHILDRENS ACETAMINOPHEN (ACETAMINOPHEN) ELIXIR [RIJ PHARMACEUTICAL CORPORATION]	1
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	CHILDRENS ACETAMINOPHEN (ACETAMINOPHEN) ELIXIR [RIJ PHARMACEUTICAL CORPORATION]	1
SACCHARIN SODIUM	INACTIVE INGREDIENT	SB8ZUX40TY	CHILDRENS ACETAMINOPHEN (ACETAMINOPHEN) ELIXIR [RIJ PHARMACEUTICAL CORPORATION]	1
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	CHILDRENS ACETAMINOPHEN (ACETAMINOPHEN) ELIXIR [RIJ PHARMACEUTICAL CORPORATION]	1
SODIUM CITRATE	INACTIVE INGREDIENT	1Q73Q2JULR	CHILDRENS ACETAMINOPHEN (ACETAMINOPHEN) ELIXIR [RIJ PHARMACEUTICAL CORPORATION]	1
SORBITOL	INACTIVE INGREDIENT	506T60A25R	CHILDRENS ACETAMINOPHEN (ACETAMINOPHEN) ELIXIR [RIJ PHARMACEUTICAL CORPORATION]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	CHILDRENS ACETAMINOPHEN (ACETAMINOPHEN) ELIXIR [RIJ PHARMACEUTICAL CORPORATION]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53807-129	CHILDRENS ACETAMINOPHEN (ACETAMINOPHEN) ELIXIR [RIJ PHARMACEUTICAL CORPORATION]	2	Legacy NDC, 6 package rows	20180502_ccc6389b-e9ed-47c2-930c-66ebf0110b0f.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	ccc6389b-e9ed-47c2-930c-66ebf0110b0f	2
307675	acetaminophen 32 MG/ML Oral Solution	SCD	ccc6389b-e9ed-47c2-930c-66ebf0110b0f	2
307675	acetaminophen 160 MG per 5 ML Oral Solution	SY	ccc6389b-e9ed-47c2-930c-66ebf0110b0f	2
307675	acetaminophen 325 MG per 10.15 ML Oral Solution	SY	ccc6389b-e9ed-47c2-930c-66ebf0110b0f	2
307675	acetaminophen 650 MG per 20.3 ML Oral Solution	SY	ccc6389b-e9ed-47c2-930c-66ebf0110b0f	2
307675	acetaminophen 80 MG per 2.5 ML Oral Solution	SY	ccc6389b-e9ed-47c2-930c-66ebf0110b0f	2
307675	APAP 32 MG/ML Oral Solution	SY	ccc6389b-e9ed-47c2-930c-66ebf0110b0f	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
53807-129-04	53807012904	118 mL in 1 BOTTLE	118 ml	Historical
53807-129-08	53807012908	236 mL in 1 BOTTLE	236 ml	Historical
53807-129-16	53807012916	473 mL in 1 BOTTLE	473 ml	Historical
53807-129-28	53807012928	3785 mL in 1 BOTTLE	3785 ml	Historical
53807-129-30	53807012930	30 mL in 1 BOTTLE	30 ml	Historical
53807-129-60	53807012960	60 mL in 1 BOTTLE	60 ml	Historical