Bismuth subsalicylate

Product NDC: 0536-4301
11-digit product format: 005364301
Labeler code: 0536
Product ID: 0536-4301_22b0e4d5-985d-4ba4-a028-9883c069d01f
Type: HUMAN OTC DRUG
Nonproprietary name: Bismuth subsalicylate
Dosage form: TABLET
Route: ORAL
Labeler: Rugby Laboratories Inc.
Application: part335
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 1996-01-23
Marketing end: 0000-00-00
Substance: BISMUTH SUBSALICYLATE
Active strength: 262 mg/1
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	0536-4301		D	Discontinued by firm		2026-08-11
excluded package	package	0536-4301	0536-4301-07	D	Discontinued by firm		2026-08-11

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 · 24 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	0536-4301-07	`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	0536-4301-07	`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	0536-4301-07	`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	0536-4301-07	`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	0536-4301-07	`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	0536-4301-07	`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	0536-4301-07	`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	0536-4301-07	`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	0536-4301-07	`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	0536-4301-07	`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	0536-4301-07	`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	0536-4301-07	`557ba5c1ecfa…`	`9c80585c8c6e…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
dea2eded-d1e7-46bb-9a3d-f8dc20de6277	Product name	1	20190408
ed912195-5da0-0f2f-6f4b-3ef17710cbe3	Product name	1	20140508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0536-4301-07	EA - Each	0536-4301	e82655bf-a65a-4ed6-b60e-5dd0daaf0560	1	2013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
BISMUTH SUBSALICYLATE	ACTIVE INGREDIENT	62TEY51RR1	BISMUTH SUBSALICYLATE TABLET [RUGBY LABORATORIES INC.]	2
SALICYLIC ACID	ACTIVE MOIETY	O414PZ4LPZ	BISMUTH SUBSALICYLATE TABLET [RUGBY LABORATORIES INC.]	2
CALCIUM CARBONATE	INACTIVE INGREDIENT	H0G9379FGK	BISMUTH SUBSALICYLATE TABLET [RUGBY LABORATORIES INC.]	2
CHERRY	INACTIVE INGREDIENT	BUC5I9595W	BISMUTH SUBSALICYLATE TABLET [RUGBY LABORATORIES INC.]	2
D&C RED NO. 27	INACTIVE INGREDIENT	2LRS185U6K	BISMUTH SUBSALICYLATE TABLET [RUGBY LABORATORIES INC.]	2
DEXTROSE	INACTIVE INGREDIENT	IY9XDZ35W2	BISMUTH SUBSALICYLATE TABLET [RUGBY LABORATORIES INC.]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	BISMUTH SUBSALICYLATE TABLET [RUGBY LABORATORIES INC.]	2
MALTODEXTRIN	INACTIVE INGREDIENT	7CVR7L4A2D	BISMUTH SUBSALICYLATE TABLET [RUGBY LABORATORIES INC.]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	BISMUTH SUBSALICYLATE TABLET [RUGBY LABORATORIES INC.]	2
SORBITOL	INACTIVE INGREDIENT	506T60A25R	BISMUTH SUBSALICYLATE TABLET [RUGBY LABORATORIES INC.]	2
BISMUTH SUBSALICYLATE	ACTIVE INGREDIENT	62TEY51RR1	PEPTIC RELIEF TABLET [REBEL DISTRIBUTORS CORP]	1
BISMUTH SUBSALICYLATE	ACTIVE MOIETY	62TEY51RR1	PEPTIC RELIEF TABLET [REBEL DISTRIBUTORS CORP]	1
CALCIUM CARBONATE	INACTIVE INGREDIENT	H0G9379FGK	PEPTIC RELIEF TABLET [REBEL DISTRIBUTORS CORP]	1
D&C RED NO. 27	INACTIVE INGREDIENT	2LRS185U6K	PEPTIC RELIEF TABLET [REBEL DISTRIBUTORS CORP]	1
DEXTROSE	INACTIVE INGREDIENT	IY9XDZ35W2	PEPTIC RELIEF TABLET [REBEL DISTRIBUTORS CORP]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	PEPTIC RELIEF TABLET [REBEL DISTRIBUTORS CORP]	1
MALTODEXTRIN	INACTIVE INGREDIENT	7CVR7L4A2D	PEPTIC RELIEF TABLET [REBEL DISTRIBUTORS CORP]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	PEPTIC RELIEF TABLET [REBEL DISTRIBUTORS CORP]	1
SORBITOL	INACTIVE INGREDIENT	506T60A25R	PEPTIC RELIEF TABLET [REBEL DISTRIBUTORS CORP]	1

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
308761	bismuth subsalicylate 262 MG Chewable Tablet	PSN	39fd1b7e-fac0-4d6f-8bc2-4af6e880a53d	1
308761	bismuth subsalicylate 262 MG Chewable Tablet	SCD	39fd1b7e-fac0-4d6f-8bc2-4af6e880a53d	1

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Peptic Relief	Rugby Laboratories Inc. \| Advance Pharmaceutical Inc.	2012-12-10	HUMAN OTC DRUG LABEL	2
Peptic Relief Drug Facts	Rebel Distributors Corp	2011-12-30	HUMAN OTC DRUG LABEL	1