Childrens Acetaminophen

Product NDC: 53807-196
11-digit product format: 538070196
Labeler code: 53807
Product ID: 53807-196_e6017e01-c08e-46f5-a111-c7b546096805
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	53807-196		I	Inactivated by FDA		2026-10-15
excluded package	package	53807-196	53807-196-04	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 1 · 42 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	53807-196-04	`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	53807-196-04	`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	53807-196-04	`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	53807-196-04	`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	53807-196-04	`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	53807-196-04	`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	53807-196-04	`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	53807-196-04	`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	53807-196-04	`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	53807-196-04	`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	53807-196-04	`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	53807-196-04	`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	53807-196-04	`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	53807-196-04	`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	53807-196-04	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	53807-196-04	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	53807-196-04	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	53807-196-04	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	53807-196-04	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	53807-196-04	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	53807-196-04	`9bebd1f3094a…`	`5416666fcb17…`

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
53807-196-04	2020-01-31	C162847	48780-1	9d75b9d1-00f6-f424-e053-dadaa90a57ce	Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
53807-196-04	Childrens Acetaminophen	118 mL in 1 BOTTLE	ELIXIR	118		2

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 BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	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 GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	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
53807-196	CHILDRENS ACETAMINOPHEN (ACETAMINOPHEN) ELIXIR [RIJ PHARMACEUTICAL CORPORATION]	2	Legacy NDC, 1 package rows	20180502_db5ce69b-0412-41b3-8362-23c1ac852fa8.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
307668	acetaminophen 160 MG in 5 mL Oral Suspension	PSN	db5ce69b-0412-41b3-8362-23c1ac852fa8	2
307668	acetaminophen 32 MG/ML Oral Suspension	SCD	db5ce69b-0412-41b3-8362-23c1ac852fa8	2
307668	acetaminophen 160 MG per 5 ML Oral Suspension	SY	db5ce69b-0412-41b3-8362-23c1ac852fa8	2
307668	acetaminophen 320 MG per 10 ML Oral Suspension	SY	db5ce69b-0412-41b3-8362-23c1ac852fa8	2
307668	acetaminophen 650 MG per 20.3 ML Oral Suspension	SY	db5ce69b-0412-41b3-8362-23c1ac852fa8	2
307668	acetaminophen 80 MG per 2.5 ML Oral Suspension	SY	db5ce69b-0412-41b3-8362-23c1ac852fa8	2
307668	APAP 32 MG/ML Oral Suspension	SY	db5ce69b-0412-41b3-8362-23c1ac852fa8	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
53807-196-04	53807019604	118 mL in 1 BOTTLE	118 ml	Historical