Bismatrol

Product NDC: 17856-1313
11-digit product format: 178561313
Labeler code: 17856
Product ID: 17856-1313_245effcb-4bdf-46ab-848c-a2c03b6e81cb
Type: HUMAN OTC DRUG
Nonproprietary name: Bismuth Subsalicylate
Dosage form: LIQUID
Route: ORAL
Labeler: ATLANTIC BIOLOGICALS CORP.
Application: part335
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2008-05-30
Marketing end: 0000-00-00
Substance: BISMUTH SUBSALICYLATE
Active strength: 262 mg/15mL
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	17856-1313		I	Inactivated by FDA	2026-10-15
excluded package	package	17856-1313	17856-1313-1	I	Inactivated by FDA	2026-10-15
excluded package	package	17856-1313	17856-1313-3	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 · 45 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	17856-1313-3	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	17856-1313-1	`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	17856-1313-3	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	17856-1313-1	`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	17856-1313-3	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	17856-1313-1	`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	17856-1313-3	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	17856-1313-1	`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	17856-1313-3	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	17856-1313-1	`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	17856-1313-3	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	17856-1313-1	`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	17856-1313-3	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	17856-1313-1	`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	17856-1313-3	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	17856-1313-1	`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	17856-1313-3	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	17856-1313-1	`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	17856-1313-3	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	17856-1313-1	`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	17856-1313-3	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	17856-1313-1	`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	17856-1313-3	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	17856-1313-1	`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	17856-1313-3	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	17856-1313-1	`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	17856-1313-3	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	17856-1313-1	`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	17856-1313-3	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	17856-1313-1	`1332a3947898…`	`d4bfe170f9cd…`

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
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
17856-1313-1	2023-01-30	C162847	48780-1	f386c649-ac7a-0266-e053-dadaa90a7c1a	Bismatrol
17856-1313-3	2023-01-30	C162847	48780-1	f386c649-ac7a-0266-e053-dadaa90a7c1a	Bismatrol

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
17856-1313-1	Bismatrol	15 mL in 1 CUP	LIQUID	15		7
17856-1313-3	Bismatrol	30 mL in 1 CUP	LIQUID	30		7

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
17856-1313-1	ML - Milliliter	17856-1313	f345f9d8-1fcb-4f62-abd6-a5eb7b4b04e6	1	2013-04-01
17856-1313-3	ML - Milliliter	17856-1313	fa1a1b7d-41c3-47b1-816b-52df0bb15feb	1	2013-04-01

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
17856-1313	BISMATROL (BISMUTH SUBSALICYLATE) LIQUID [ATLANTIC BIOLOGICALS CORP.]	7	Legacy NDC, 2 package rows	20210114_a266f599-2f2c-416f-9ef9-a1d3db552c89.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
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
17856-1313-1	17856131301	15 mL in 1 CUP (17856-1313-1)	15 ml	2021-01-13	0000-00-00	No	No	Current
17856-1313-3	17856131303	30 mL in 1 CUP (17856-1313-3)	30 ml	2021-01-13	0000-00-00	No	No	Current