Pink Bismuth Maximum Strength

Product NDC: 53807-192
11-digit product format: 538070192
Labeler code: 53807
Product ID: 53807-192_1733830f-ea50-49aa-abab-1cfa94773c85
Type: HUMAN OTC DRUG
Nonproprietary name: Bismuth Subsalicylate
Dosage form: LIQUID
Route: ORAL
Labeler: Rij Pharmaceutical Corporation
Application: part335
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 1999-03-16
Marketing end: 0000-00-00
Substance: BISMUTH SUBSALICYLATE
Active strength: 525 mg/15mL
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	53807-192		I	Inactivated by FDA		2026-10-15
excluded package	package	53807-192	53807-192-08	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	53807-192-08	`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	53807-192-08	`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	53807-192-08	`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	53807-192-08	`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	53807-192-08	`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	53807-192-08	`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	53807-192-08	`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	53807-192-08	`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	53807-192-08	`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	53807-192-08	`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	53807-192-08	`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	53807-192-08	`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	53807-192-08	`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	53807-192-08	`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	53807-192-08	`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	53807-192-08	`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	53807-192-08	`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	53807-192-08	`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	53807-192-08	`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	53807-192-08	`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	53807-192-08	`9bebd1f3094a…`	`5416666fcb17…`

Reported adverse events (FAERS/openFDA)#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
0be8e4ae-4d57-49f3-b3a9-e4728b4e8d15	Product name	1	20240313
dea2eded-d1e7-46bb-9a3d-f8dc20de6277	Product name	1	20190408

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
53807-192-08	2020-01-31	C162847	48780-1	9d75b9d0-d468-f424-e053-dadaa90a57ce	Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
53807-192-08	Pink Bismuth Maximum Strength	237 mL in 1 BOTTLE	LIQUID	237		2

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
BISMUTH SUBSALICYLATE	ACTIVE INGREDIENT	62TEY51RR1	PINK BISMUTH MAXIMUM STRENGTH (BISMUTH SUBSALICYLATE) LIQUID [RIJ PHARMACEUTICAL CORPORATION]	1
BISMUTH CATION	ACTIVE MOIETY	ZS9CD1I8YE	PINK BISMUTH MAXIMUM STRENGTH (BISMUTH SUBSALICYLATE) LIQUID [RIJ PHARMACEUTICAL CORPORATION]	1
CARBOXYMETHYLCELLULOSE SODIUM	INACTIVE INGREDIENT	K679OBS311	PINK BISMUTH MAXIMUM STRENGTH (BISMUTH SUBSALICYLATE) LIQUID [RIJ PHARMACEUTICAL CORPORATION]	1
FD&C RED NO. 3	INACTIVE INGREDIENT	PN2ZH5LOQY	PINK BISMUTH MAXIMUM STRENGTH (BISMUTH SUBSALICYLATE) LIQUID [RIJ PHARMACEUTICAL CORPORATION]	1
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	PINK BISMUTH MAXIMUM STRENGTH (BISMUTH SUBSALICYLATE) LIQUID [RIJ PHARMACEUTICAL CORPORATION]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	PINK BISMUTH MAXIMUM STRENGTH (BISMUTH SUBSALICYLATE) LIQUID [RIJ PHARMACEUTICAL CORPORATION]	1
MAGNESIUM ALUMINUM SILICATE	INACTIVE INGREDIENT	6M3P64V0NC	PINK BISMUTH MAXIMUM STRENGTH (BISMUTH SUBSALICYLATE) LIQUID [RIJ PHARMACEUTICAL CORPORATION]	1
SACCHARIN SODIUM	INACTIVE INGREDIENT	SB8ZUX40TY	PINK BISMUTH MAXIMUM STRENGTH (BISMUTH SUBSALICYLATE) LIQUID [RIJ PHARMACEUTICAL CORPORATION]	1
SALICYLIC ACID	INACTIVE INGREDIENT	O414PZ4LPZ	PINK BISMUTH MAXIMUM STRENGTH (BISMUTH SUBSALICYLATE) LIQUID [RIJ PHARMACEUTICAL CORPORATION]	1
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	PINK BISMUTH MAXIMUM STRENGTH (BISMUTH SUBSALICYLATE) LIQUID [RIJ PHARMACEUTICAL CORPORATION]	1
SODIUM SALICYLATE	INACTIVE INGREDIENT	WIQ1H85SYP	PINK BISMUTH MAXIMUM STRENGTH (BISMUTH SUBSALICYLATE) LIQUID [RIJ PHARMACEUTICAL CORPORATION]	1
SORBITOL	INACTIVE INGREDIENT	506T60A25R	PINK BISMUTH MAXIMUM STRENGTH (BISMUTH SUBSALICYLATE) LIQUID [RIJ PHARMACEUTICAL CORPORATION]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	PINK BISMUTH MAXIMUM STRENGTH (BISMUTH SUBSALICYLATE) LIQUID [RIJ PHARMACEUTICAL CORPORATION]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53807-192	PINK BISMUTH MAXIMUM STRENGTH (BISMUTH SUBSALICYLATE) LIQUID [RIJ PHARMACEUTICAL CORPORATION]	2	Legacy NDC, 1 package rows	20180502_e2f824e8-5e60-4791-9393-7f200b3bba8a.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
62TEY51RR1	BISMUTH SUBSALICYLATE	14882-18-9	BISMUTH SUBSALICYLATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
308763	bismuth subsalicylate 1050 MG in 30 mL Oral Suspension	PSN	e2f824e8-5e60-4791-9393-7f200b3bba8a	2
308763	bismuth subsalicylate 35 MG/ML Oral Suspension	SCD	e2f824e8-5e60-4791-9393-7f200b3bba8a	2
308763	bismuth subsalicylate 1050 MG per 30 ML Oral Suspension	SY	e2f824e8-5e60-4791-9393-7f200b3bba8a	2
308763	bismuth subsalicylate 525 MG per 15 ML Oral Suspension	SY	e2f824e8-5e60-4791-9393-7f200b3bba8a	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
53807-192-08	53807019208	237 mL in 1 BOTTLE	237 ml	Historical