Broncomar

Product NDC: 53113-216
11-digit product format: 531130216
Labeler code: 53113
Product ID: 53113-216_9093948c-6ef7-48ce-b023-8d979a924cde
Type: HUMAN OTC DRUG
Nonproprietary name: Dextromethorphan HBr, Guaifenesin
Dosage form: LIQUID
Route: ORAL
Labeler: Gadal Laboratories Inc
Application: part341
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2014-06-01
Marketing end: 0000-00-00
Substance: DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Active strength: 30 mg/10mL; mg/10mL
NDC exclude flag: E
Listing certified through: 2017-12-31
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	53113-216		I	Inactivated by FDA		2026-10-05
excluded package	package	53113-216	53113-216-06	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 · 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	53113-216-06	`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	53113-216-06	`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	53113-216-06	`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	53113-216-06	`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	53113-216-06	`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	53113-216-06	`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	53113-216-06	`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	53113-216-06	`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	53113-216-06	`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	53113-216-06	`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	53113-216-06	`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	53113-216-06	`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	53113-216-06	`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	53113-216-06	`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	53113-216-06	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	53113-216-06	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	53113-216-06	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	53113-216-06	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	53113-216-06	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	53113-216-06	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	53113-216-06	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	53113-216-06	`110d247fa046…`	`a55b01930146…`

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
4fe95224-f543-4dbb-9445-8cca122b48c8	Product name	1	20150609
e8718272-64cb-4436-969b-176c3067c8f4	Product name	1	20150609
106ff02a-57e1-4c4c-a307-fd582ff4e311	Product name	1	20150212

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
53113-216-06	2019-11-27	C162847	48780-1	9855e2a2-3ccc-60a7-e053-dbdaa90a05bd	afbee087-62dc-4f5d-8155-2d6c1de320ed

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
53113-216-06	BroncomarMaximum	177 mL in 1 BOTTLE	LIQUID	177		1
53113-216-06	BroncomarMaximum	1 in 1 CARTON	LIQUID	1		1

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DEXTROMETHORPHAN HYDROBROMIDE	ACTIVE INGREDIENT	9D2RTI9KYH	BRONCOMAR MAXIMUM (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [GADAL LABORATORIES INC]	1
GUAIFENESIN	ACTIVE INGREDIENT	495W7451VQ	BRONCOMAR MAXIMUM (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [GADAL LABORATORIES INC]	1
DEXTROMETHORPHAN	ACTIVE MOIETY	7355X3ROTS	BRONCOMAR MAXIMUM (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [GADAL LABORATORIES INC]	1
GUAIFENESIN	ACTIVE MOIETY	495W7451VQ	BRONCOMAR MAXIMUM (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [GADAL LABORATORIES INC]	1
ALOE VERA WHOLE	INACTIVE INGREDIENT	KIZ4X2EHYX	BRONCOMAR MAXIMUM (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [GADAL LABORATORIES INC]	1
ANHYDROUS CITRIC ACID	INACTIVE INGREDIENT	XF417D3PSL	BRONCOMAR MAXIMUM (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [GADAL LABORATORIES INC]	1
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	BRONCOMAR MAXIMUM (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [GADAL LABORATORIES INC]	1
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	BRONCOMAR MAXIMUM (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [GADAL LABORATORIES INC]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	BRONCOMAR MAXIMUM (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [GADAL LABORATORIES INC]	1
HYDROXYMETHYL CELLULOSE	INACTIVE INGREDIENT	273FM27VK1	BRONCOMAR MAXIMUM (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [GADAL LABORATORIES INC]	1
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	BRONCOMAR MAXIMUM (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [GADAL LABORATORIES INC]	1
SORBITOL	INACTIVE INGREDIENT	506T60A25R	BRONCOMAR MAXIMUM (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [GADAL LABORATORIES INC]	1
SUCRALOSE	INACTIVE INGREDIENT	96K6UQ3ZD4	BRONCOMAR MAXIMUM (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [GADAL LABORATORIES INC]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	BRONCOMAR MAXIMUM (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [GADAL LABORATORIES INC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53113-216	BRONCOMAR MAXIMUM (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [GADAL LABORATORIES INC]	1	Legacy NDC, 2 package rows	20140613_afbee087-62dc-4f5d-8155-2d6c1de320ed.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
9D2RTI9KYH	DEXTROMETHORPHAN HYDROBROMIDE	6700-34-1	DEXTROMETHORPHAN HYDROBROMIDE
495W7451VQ	GUAIFENESIN	93-14-1	GUAIFENESIN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1234473	dextromethorphan HBr 30 MG / guaiFENesin 200 MG in 10 mL Oral Solution	PSN	afbee087-62dc-4f5d-8155-2d6c1de320ed	1
1234473	dextromethorphan hydrobromide 3 MG/ML / guaifenesin 20 MG/ML Oral Solution	SCD	afbee087-62dc-4f5d-8155-2d6c1de320ed	1
1234473	dextromethorphan hydrobromide 15 MG / guaifenesin 100 MG per 5 ML Oral Solution	SY	afbee087-62dc-4f5d-8155-2d6c1de320ed	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
53113-216-06	53113021606	177 mL in 1 BOTTLE	177 ml	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Broncomar Maximum - Gadal Laboratories Inc	Gadal Laboratories Inc	2014-06-12	HUMAN OTC DRUG LABEL	1