Bismatrol

Product NDC: 0904-1313
11-digit product format: 009041313
Labeler code: 0904
Product ID: 0904-1313_332a78df-80f8-45aa-91a3-dc762b8bc8a3
Type: HUMAN OTC DRUG
Nonproprietary name: Bismuth Subsalicylate
Dosage form: LIQUID
Route: ORAL
Labeler: Major Pharmaceuticals
Application: part335
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2008-05-30
Marketing end: 2021-02-28
Substance: BISMUTH SUBSALICYLATE
Active strength: 262 mg/15mL
NDC exclude flag: No
Listing certified through: 0000-00-00
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	0904-1313		D	Discontinued by firm		2026-08-11
excluded package	package	0904-1313	0904-1313-09	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	0904-1313-09	`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	0904-1313-09	`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	0904-1313-09	`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	0904-1313-09	`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	0904-1313-09	`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	0904-1313-09	`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	0904-1313-09	`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	0904-1313-09	`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	0904-1313-09	`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	0904-1313-09	`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	0904-1313-09	`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	0904-1313-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
0be8e4ae-4d57-49f3-b3a9-e4728b4e8d15	Product name	1	20240313
c6f86816-7da6-43ea-8c25-ac9758311cc5	Product name	1	20220118
dea2eded-d1e7-46bb-9a3d-f8dc20de6277	Product name	1	20190408
252e11b6-1a9a-4283-a242-df2c129c496d	Product name	3	20170717

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0904-1313-09	ML - Milliliter	0904-1313	56076192-e0b3-49bb-ba2d-88b6f259e9c2	1	2013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
BISMUTH SUBSALICYLATE	ACTIVE INGREDIENT	62TEY51RR1	BISMATROL (BISMUTH SUBSALICYLATE) LIQUID [ATLANTIC BIOLOGICALS CORPS]	5
BISMUTH CATION	ACTIVE MOIETY	ZS9CD1I8YE	BISMATROL (BISMUTH SUBSALICYLATE) LIQUID [ATLANTIC BIOLOGICALS CORPS]	5
BENZOIC ACID	INACTIVE INGREDIENT	8SKN0B0MIM	BISMATROL (BISMUTH SUBSALICYLATE) LIQUID [ATLANTIC BIOLOGICALS CORPS]	5
D&C RED NO. 22	INACTIVE INGREDIENT	1678RKX8RT	BISMATROL (BISMUTH SUBSALICYLATE) LIQUID [ATLANTIC BIOLOGICALS CORPS]	5
D&C RED NO. 28	INACTIVE INGREDIENT	767IP0Y5NH	BISMATROL (BISMUTH SUBSALICYLATE) LIQUID [ATLANTIC BIOLOGICALS CORPS]	5
DIMETHICONE	INACTIVE INGREDIENT	92RU3N3Y1O	BISMATROL (BISMUTH SUBSALICYLATE) LIQUID [ATLANTIC BIOLOGICALS CORPS]	5
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%)	INACTIVE INGREDIENT	S38J6RZN16	BISMATROL (BISMUTH SUBSALICYLATE) LIQUID [ATLANTIC BIOLOGICALS CORPS]	5
POTASSIUM HYDROXIDE	INACTIVE INGREDIENT	WZH3C48M4T	BISMATROL (BISMUTH SUBSALICYLATE) LIQUID [ATLANTIC BIOLOGICALS CORPS]	5
SACCHARIN SODIUM DIHYDRATE	INACTIVE INGREDIENT	SB8ZUX40TY	BISMATROL (BISMUTH SUBSALICYLATE) LIQUID [ATLANTIC BIOLOGICALS CORPS]	5
SALICYLIC ACID	INACTIVE INGREDIENT	O414PZ4LPZ	BISMATROL (BISMUTH SUBSALICYLATE) LIQUID [ATLANTIC BIOLOGICALS CORPS]	5
WATER	INACTIVE INGREDIENT	059QF0KO0R	BISMATROL (BISMUTH SUBSALICYLATE) LIQUID [ATLANTIC BIOLOGICALS CORPS]	5
XANTHAN GUM	INACTIVE INGREDIENT	TTV12P4NEE	BISMATROL (BISMUTH SUBSALICYLATE) LIQUID [ATLANTIC BIOLOGICALS CORPS]	5
BISMUTH SUBSALICYLATE	ACTIVE INGREDIENT	62TEY51RR1	BISMATROL (BISMUTH SUBSALICYLATE) LIQUID [AIDAREX PHARMACEUTICALS LLC]	1
BISMUTH SUBSALICYLATE	ACTIVE INGREDIENT	62TEY51RR1	BISMATROL (BISMUTH SUBSALICYLATE) LIQUID [MAJOR PHARMACEUTICALS]	1
BISMUTH CATION	ACTIVE MOIETY	ZS9CD1I8YE	BISMATROL (BISMUTH SUBSALICYLATE) LIQUID [AIDAREX PHARMACEUTICALS LLC]	1
BISMUTH CATION	ACTIVE MOIETY	ZS9CD1I8YE	BISMATROL (BISMUTH SUBSALICYLATE) LIQUID [MAJOR PHARMACEUTICALS]	1
BENZOIC ACID	INACTIVE INGREDIENT	8SKN0B0MIM	BISMATROL (BISMUTH SUBSALICYLATE) LIQUID [MAJOR PHARMACEUTICALS]	1
BENZOIC ACID	INACTIVE INGREDIENT	8SKN0B0MIM	BISMATROL (BISMUTH SUBSALICYLATE) LIQUID [AIDAREX PHARMACEUTICALS LLC]	1
D&C RED NO. 22	INACTIVE INGREDIENT	1678RKX8RT	BISMATROL (BISMUTH SUBSALICYLATE) LIQUID [MAJOR PHARMACEUTICALS]	1
D&C RED NO. 22	INACTIVE INGREDIENT	1678RKX8RT	BISMATROL (BISMUTH SUBSALICYLATE) LIQUID [AIDAREX PHARMACEUTICALS LLC]	1
D&C RED NO. 28	INACTIVE INGREDIENT	767IP0Y5NH	BISMATROL (BISMUTH SUBSALICYLATE) LIQUID [MAJOR PHARMACEUTICALS]	1
D&C RED NO. 28	INACTIVE INGREDIENT	767IP0Y5NH	BISMATROL (BISMUTH SUBSALICYLATE) LIQUID [AIDAREX PHARMACEUTICALS LLC]	1
DIMETHICONE	INACTIVE INGREDIENT	92RU3N3Y1O	BISMATROL (BISMUTH SUBSALICYLATE) LIQUID [AIDAREX PHARMACEUTICALS LLC]	1
DIMETHICONE	INACTIVE INGREDIENT	92RU3N3Y1O	BISMATROL (BISMUTH SUBSALICYLATE) LIQUID [MAJOR PHARMACEUTICALS]	1
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%)	INACTIVE INGREDIENT	S38J6RZN16	BISMATROL (BISMUTH SUBSALICYLATE) LIQUID [MAJOR PHARMACEUTICALS]	1
HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)	INACTIVE INGREDIENT	S38J6RZN16	BISMATROL (BISMUTH SUBSALICYLATE) LIQUID [AIDAREX PHARMACEUTICALS LLC]	1
POTASSIUM HYDROXIDE	INACTIVE INGREDIENT	WZH3C48M4T	BISMATROL (BISMUTH SUBSALICYLATE) LIQUID [MAJOR PHARMACEUTICALS]	1
POTASSIUM HYDROXIDE	INACTIVE INGREDIENT	WZH3C48M4T	BISMATROL (BISMUTH SUBSALICYLATE) LIQUID [AIDAREX PHARMACEUTICALS LLC]	1
SACCHARIN SODIUM	INACTIVE INGREDIENT	SB8ZUX40TY	BISMATROL (BISMUTH SUBSALICYLATE) LIQUID [AIDAREX PHARMACEUTICALS LLC]	1
SACCHARIN SODIUM DIHYDRATE	INACTIVE INGREDIENT	SB8ZUX40TY	BISMATROL (BISMUTH SUBSALICYLATE) LIQUID [MAJOR PHARMACEUTICALS]	1
SALICYLIC ACID	INACTIVE INGREDIENT	O414PZ4LPZ	BISMATROL (BISMUTH SUBSALICYLATE) LIQUID [AIDAREX PHARMACEUTICALS LLC]	1
SALICYLIC ACID	INACTIVE INGREDIENT	O414PZ4LPZ	BISMATROL (BISMUTH SUBSALICYLATE) LIQUID [MAJOR PHARMACEUTICALS]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	BISMATROL (BISMUTH SUBSALICYLATE) LIQUID [AIDAREX PHARMACEUTICALS LLC]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	BISMATROL (BISMUTH SUBSALICYLATE) LIQUID [MAJOR PHARMACEUTICALS]	1
XANTHAN GUM	INACTIVE INGREDIENT	TTV12P4NEE	BISMATROL (BISMUTH SUBSALICYLATE) LIQUID [MAJOR PHARMACEUTICALS]	1
XANTHAN GUM	INACTIVE INGREDIENT	TTV12P4NEE	BISMATROL (BISMUTH SUBSALICYLATE) LIQUID [AIDAREX PHARMACEUTICALS LLC]	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
308762	bismuth subsalicylate 525 MG in 30 mL Oral Suspension	PSN	a266f599-2f2c-416f-9ef9-a1d3db552c89	7
308762	bismuth subsalicylate 17.5 MG/ML Oral Suspension	SCD	a266f599-2f2c-416f-9ef9-a1d3db552c89	7
308762	bismuth subsalicylate 1.75 % Oral Suspension	SY	a266f599-2f2c-416f-9ef9-a1d3db552c89	7
308762	bismuth subsalicylate 262 MG per 15 ML Oral Suspension	SY	a266f599-2f2c-416f-9ef9-a1d3db552c89	7
308762	bismuth subsalicylate 524 MG per 30 ML Oral Suspension	SY	a266f599-2f2c-416f-9ef9-a1d3db552c89	7
308762	bismuth subsalicylate 525 MG per 30 ML Oral Suspension	SY	a266f599-2f2c-416f-9ef9-a1d3db552c89	7
308762	bismuth subsalicylate 525 MG in 30 mL Oral Suspension	PSN	c99c1061-baa4-4c0f-bbae-3d1eea43a6a5	2
308762	bismuth subsalicylate 17.5 MG/ML Oral Suspension	SCD	c99c1061-baa4-4c0f-bbae-3d1eea43a6a5	2
308762	bismuth subsalicylate 1.75 % Oral Suspension	SY	c99c1061-baa4-4c0f-bbae-3d1eea43a6a5	2
308762	bismuth subsalicylate 262 MG per 15 ML Oral Suspension	SY	c99c1061-baa4-4c0f-bbae-3d1eea43a6a5	2
308762	bismuth subsalicylate 524 MG per 30 ML Oral Suspension	SY	c99c1061-baa4-4c0f-bbae-3d1eea43a6a5	2
308762	bismuth subsalicylate 525 MG per 30 ML Oral Suspension	SY	c99c1061-baa4-4c0f-bbae-3d1eea43a6a5	2
308762	bismuth subsalicylate 525 MG in 30 mL Oral Suspension	PSN	6b4d6e96-4d67-43cd-b4ff-8d02e80e0b3c	1
308762	bismuth subsalicylate 17.5 MG/ML Oral Suspension	SCD	6b4d6e96-4d67-43cd-b4ff-8d02e80e0b3c	1
308762	bismuth subsalicylate 1.75 % Oral Suspension	SY	6b4d6e96-4d67-43cd-b4ff-8d02e80e0b3c	1
308762	bismuth subsalicylate 262 MG per 15 ML Oral Suspension	SY	6b4d6e96-4d67-43cd-b4ff-8d02e80e0b3c	1
308762	bismuth subsalicylate 524 MG per 30 ML Oral Suspension	SY	6b4d6e96-4d67-43cd-b4ff-8d02e80e0b3c	1
308762	bismuth subsalicylate 525 MG per 30 ML Oral Suspension	SY	6b4d6e96-4d67-43cd-b4ff-8d02e80e0b3c	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0904-1313-09	00904131309	236 mL in 1 BOTTLE (0904-1313-09)	236 ml	2008-05-30	2021-02-28	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Bismuth Subsalicylate	Lohxa	2021-02-25	HUMAN OTC DRUG LABEL	2
Bismatrol	ATLANTIC BIOLOGICALS CORP.	2021-01-13	HUMAN OTC DRUG LABEL	7
Bismatrol	Major Pharmaceuticals	2020-12-09	HUMAN OTC DRUG LABEL	5
Bismatrol	Proficient Rx LP	2019-11-01	HUMAN OTC DRUG LABEL	3
Bismatrol	Aidarex Pharmaceuticals LLC	2013-12-13	HUMAN OTC DRUG LABEL	1