Stomach Relief

Product NDC: 49580-0372
11-digit product format: 495800372
Labeler code: 49580
Product ID: 49580-0372_75210c08-664f-4a35-a366-8a994011c360
Type: HUMAN OTC DRUG
Nonproprietary name: Bismuth subsalicylate
Dosage form: LIQUID
Route: ORAL
Labeler: P & L Development, LLC
Application: part335
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2014-09-30
Marketing end: 0000-00-00
Substance: BISMUTH SUBSALICYLATE
Active strength: 525 mg/30mL
NDC exclude flag: No
Listing certified through: 2020-12-31
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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	49580-0372		D	Discontinued by firm	2026-10-12
excluded package	package	49580-0372	49580-0372-6	D	Discontinued by firm	2026-10-12
excluded package	package	49580-0372	49580-0372-7	D	Discontinued by firm	2026-10-12
excluded package	package	49580-0372	49580-0372-8	D	Discontinued by firm	2026-10-12

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 · 44 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	49580-0372-7	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	49580-0372-8	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	49580-0372-6	`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	49580-0372-7	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	49580-0372-8	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	49580-0372-6	`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	49580-0372-7	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	49580-0372-8	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	49580-0372-6	`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	49580-0372-7	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	49580-0372-8	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	49580-0372-6	`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	49580-0372-7	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	49580-0372-8	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	49580-0372-6	`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	49580-0372-7	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	49580-0372-8	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	49580-0372-6	`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	49580-0372-7	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	49580-0372-8	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	49580-0372-6	`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	49580-0372-7	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	49580-0372-8	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	49580-0372-6	`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	49580-0372-7	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	49580-0372-8	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	49580-0372-6	`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	49580-0372-7	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	49580-0372-8	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	49580-0372-6	`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	49580-0372-7	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	49580-0372-8	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	49580-0372-6	`367a005e9d99…`	`383a685ebd0f…`

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
49580-0372-6	2023-05-24	Drug Facts
49580-0372-7	2023-05-24	Drug Facts
49580-0372-8	2023-05-24	Drug Facts
49580-0372-6	2023-01-30	Drug Facts
49580-0372-7	2023-01-30	Drug Facts
49580-0372-8	2023-01-30	Drug Facts

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
BISMUTH SUBSALICYLATE	ACTIVE INGREDIENT	62TEY51RR1	STOMACH RELIEF REGULAR STRENGTH READYINCASE (BISMUTH SUBSALICYLATE) LIQUID [P & L DEVELOPMENT, LLC]	3
SALICYLIC ACID	ACTIVE MOIETY	O414PZ4LPZ	STOMACH RELIEF REGULAR STRENGTH READYINCASE (BISMUTH SUBSALICYLATE) LIQUID [P & L DEVELOPMENT, LLC]	3
BENZOIC ACID	INACTIVE INGREDIENT	8SKN0B0MIM	STOMACH RELIEF REGULAR STRENGTH READYINCASE (BISMUTH SUBSALICYLATE) LIQUID [P & L DEVELOPMENT, LLC]	3
D&C RED NO. 22	INACTIVE INGREDIENT	1678RKX8RT	STOMACH RELIEF REGULAR STRENGTH READYINCASE (BISMUTH SUBSALICYLATE) LIQUID [P & L DEVELOPMENT, LLC]	3
D&C RED NO. 28	INACTIVE INGREDIENT	767IP0Y5NH	STOMACH RELIEF REGULAR STRENGTH READYINCASE (BISMUTH SUBSALICYLATE) LIQUID [P & L DEVELOPMENT, LLC]	3
MAGNESIUM ALUMINUM SILICATE	INACTIVE INGREDIENT	6M3P64V0NC	STOMACH RELIEF REGULAR STRENGTH READYINCASE (BISMUTH SUBSALICYLATE) LIQUID [P & L DEVELOPMENT, LLC]	3
METHYLCELLULOSE (1500 MPA.S)	INACTIVE INGREDIENT	P0NTE48364	STOMACH RELIEF REGULAR STRENGTH READYINCASE (BISMUTH SUBSALICYLATE) LIQUID [P & L DEVELOPMENT, LLC]	3
SACCHARIN SODIUM	INACTIVE INGREDIENT	SB8ZUX40TY	STOMACH RELIEF REGULAR STRENGTH READYINCASE (BISMUTH SUBSALICYLATE) LIQUID [P & L DEVELOPMENT, LLC]	3
SALICYLIC ACID	INACTIVE INGREDIENT	O414PZ4LPZ	STOMACH RELIEF REGULAR STRENGTH READYINCASE (BISMUTH SUBSALICYLATE) LIQUID [P & L DEVELOPMENT, LLC]	3
SODIUM SALICYLATE	INACTIVE INGREDIENT	WIQ1H85SYP	STOMACH RELIEF REGULAR STRENGTH READYINCASE (BISMUTH SUBSALICYLATE) LIQUID [P & L DEVELOPMENT, LLC]	3
SORBIC ACID	INACTIVE INGREDIENT	X045WJ989B	STOMACH RELIEF REGULAR STRENGTH READYINCASE (BISMUTH SUBSALICYLATE) LIQUID [P & L DEVELOPMENT, LLC]	3
WATER	INACTIVE INGREDIENT	059QF0KO0R	STOMACH RELIEF REGULAR STRENGTH READYINCASE (BISMUTH SUBSALICYLATE) LIQUID [P & L DEVELOPMENT, LLC]	3

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
49580-0372-6	49580037206	177 mL in 1 BOTTLE, PLASTIC (49580-0372-6)	177 ml	2014-09-30	0000-00-00	No	No	Current
49580-0372-7	49580037207	473 mL in 1 BOTTLE, PLASTIC (49580-0372-7)	473 ml	2014-09-30	0000-00-00	No	No	Current
49580-0372-8	49580037208	237 mL in 1 BOTTLE, PLASTIC (49580-0372-8)	237 ml	2014-09-30	0000-00-00	No	No	Current