Pepto-Bismol

Product NDC: 50090-0553
Requested package NDC: 50090-0553-0
11-digit product format: 500900553
Labeler code: 50090
Product ID: 50090-0553_5ee510fb-cf8a-49e9-aa7e-6f9cd441fdef
Type: HUMAN OTC DRUG
Nonproprietary name: Bismuth subsalicylate
Dosage form: TABLET
Route: ORAL
Labeler: A-S Medication Solutions
Application: part335
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2004-06-30
Marketing end: 0000-00-00
Substance: BISMUTH SUBSALICYLATE
Active strength: 262 mg/1
NDC exclude flag: No
Listing certified through: 2022-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	50090-0553	50090-0553-0	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 1 · 9 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Code, Status table
Captured / source date	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`

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
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
50090-0553-0	2025-01-30	C162847	48780-1	f386c64a-459f-0266-e053-dadaa90a7c1a	Pepto-Bismol™
50090-0553-0	2023-02-07	C162847	48780-1	f386c64a-459f-0266-e053-dadaa90a7c1a	Pepto-Bismol™
50090-0553-0	2023-01-30	C162847	48780-1	f386c64a-459f-0266-e053-dadaa90a7c1a	Pepto-Bismol™

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
50090-0553-0	Pepto-Bismol	6 in 1 CELLO PACK	TABLET	6		17
50090-0553-0	Pepto-Bismol	5 in 1 CARTON	TABLET	5		17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50090-0553-0	EA - Each	50090-0553	f53d9a8a-fa2a-4c35-aed3-f1eecf4d4942	1	2024-08-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50090-0553	PEPTO-BISMOL (BISMUTH SUBSALICYLATE) TABLET [A-S MEDICATION SOLUTIONS]	17	Legacy NDC, 2 package rows	20230208_e02bead2-0be9-41b0-98a7-fd0c3f57def0.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
308761	bismuth subsalicylate 262 MG Chewable Tablet	PSN	e02bead2-0be9-41b0-98a7-fd0c3f57def0	17
211151	Pepto-Bismol 262 MG Chewable Tablet	PSN	e02bead2-0be9-41b0-98a7-fd0c3f57def0	17
211151	bismuth subsalicylate 262 MG Chewable Tablet [Pepto-bismol]	SBD	e02bead2-0be9-41b0-98a7-fd0c3f57def0	17
308761	bismuth subsalicylate 262 MG Chewable Tablet	SCD	e02bead2-0be9-41b0-98a7-fd0c3f57def0	17
211151	Pepto-bismol 262 MG Chewable Tablet	SY	e02bead2-0be9-41b0-98a7-fd0c3f57def0	17
211151	Pepto-Bismol InstaCool 262 MG Chewable Tablet	SY	e02bead2-0be9-41b0-98a7-fd0c3f57def0	17
211151	Pepto-Bismol To-Go 262 MG Chewable Tablet	SY	e02bead2-0be9-41b0-98a7-fd0c3f57def0	17

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50090-0553-0	50090055300	5 CELLO PACK in 1 CARTON (50090-0553-0) > 6 TABLET in 1 CELLO PACK	5 cello pack	2014-11-28	0000-00-00	No	No	Current