Broncomar

Product NDC: 53113-218
11-digit product format: 531130218
Labeler code: 53113
Product ID: 53113-218_1f890f7c-0ae0-4746-ad5e-de73ba503801
Type: HUMAN OTC DRUG
Nonproprietary name: 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: GUAIFENESIN
Active strength: 100 mg/5mL
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	53113-218		I	Inactivated by FDA		2026-10-05
excluded package	package	53113-218	53113-218-06	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	53113-218-06	`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	53113-218-06	`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	53113-218-06	`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	53113-218-06	`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	53113-218-06	`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	53113-218-06	`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	53113-218-06	`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	53113-218-06	`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	53113-218-06	`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	53113-218-06	`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	53113-218-06	`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	53113-218-06	`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	53113-218-06	`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	53113-218-06	`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	53113-218-06	`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	53113-218-06	`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	53113-218-06	`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	53113-218-06	`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	53113-218-06	`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	53113-218-06	`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	53113-218-06	`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	53113-218-06	`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
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
e2db08c6-133f-4f4f-afb4-e90a2418d6f6	Product name	1	20230320
6bd95106-a412-1dad-b9cc-4cb74bfb27ce	Product name	2	20230315
c6f86816-7da6-43ea-8c25-ac9758311cc5	Product name	1	20220118
f1e0dc7e-7d61-4625-b6d9-4894927679d7	Product name	2	20211025
3c386306-c48a-413e-bb69-70cb268496f3	Product name	1	20210727
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906	Product name	7	20210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029
e4870509-7e28-6f92-f0be-dd3dd889a9cf	Product name	5	20200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cd	Product name	2	20190619
444b3e50-f226-46ef-bfca-2e7035d140cd	Product name	1	20190611
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
11ed6f83-cdd2-4637-8379-b1a1d3ae3cde	Product name	1	20181101
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
86c45a79-b9f0-4476-a27c-6e10db098497	Product name	1	20180125
252e11b6-1a9a-4283-a242-df2c129c496d	Product name	3	20170717
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
290f523a-f9db-9774-b5a9-e1f908ac1782	Product name	1	20150828
4fe95224-f543-4dbb-9445-8cca122b48c8	Product name	1	20150609
e8718272-64cb-4436-969b-176c3067c8f4	Product name	1	20150609
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
106ff02a-57e1-4c4c-a307-fd582ff4e311	Product name	1	20150212
5668b646-cd56-c3c7-bdea-3f6b1a8840db	Product name	1	20140508
684ea482-2e8b-14af-5664-b98f1e402036	Product name	1	20140508
810ab97e-f109-f41c-7c83-6a652a9cbf43	Product name	1	20140508
87711080-88eb-65c5-b2dd-bf99e700a372	Product name	1	20140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2dd	Product name	1	20140508
b060cc1a-fe47-856b-0b77-4448b5963de8	Product name	1	20140508
c6b65c52-69c7-df49-550a-a50c137f6218	Product name	1	20140508
ec2149b3-5c6d-5344-f757-c86411073075	Product name	1	20140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
53113-218-06	2019-11-27	C162847	48780-1	9855e2a2-33d2-60a7-e053-dbdaa90a05bd	01bae271-502b-4345-b114-0072c39b4dba

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
53113-218-06	BroncomarSF	177 mL in 1 BOTTLE	LIQUID	177		1
53113-218-06	BroncomarSF	1 in 1 CARTON	LIQUID	1		1

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
GUAIFENESIN	ACTIVE INGREDIENT	495W7451VQ	BRONCOMAR SF (GUAIFENESIN) LIQUID [GADAL LABORATORIES INC]	1
GUAIFENESIN	ACTIVE MOIETY	495W7451VQ	BRONCOMAR SF (GUAIFENESIN) LIQUID [GADAL LABORATORIES INC]	1
ANHYDROUS CITRIC ACID	INACTIVE INGREDIENT	XF417D3PSL	BRONCOMAR SF (GUAIFENESIN) LIQUID [GADAL LABORATORIES INC]	1
CAULOPHYLLUM THALICTROIDES ROOT	INACTIVE INGREDIENT	JTJ6HH6YEH	BRONCOMAR SF (GUAIFENESIN) LIQUID [GADAL LABORATORIES INC]	1
ECHINACEA, UNSPECIFIED	INACTIVE INGREDIENT	4N9P6CC1DX	BRONCOMAR SF (GUAIFENESIN) LIQUID [GADAL LABORATORIES INC]	1
EUCALYPTUS CAMALDULENSIS LEAF OIL	INACTIVE INGREDIENT	SN6D1J15I6	BRONCOMAR SF (GUAIFENESIN) LIQUID [GADAL LABORATORIES INC]	1
GINKGO BILOBA WHOLE	INACTIVE INGREDIENT	660486U6OI	BRONCOMAR SF (GUAIFENESIN) LIQUID [GADAL LABORATORIES INC]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	BRONCOMAR SF (GUAIFENESIN) LIQUID [GADAL LABORATORIES INC]	1
GOLDENSEAL	INACTIVE INGREDIENT	ZW3Z11D0JV	BRONCOMAR SF (GUAIFENESIN) LIQUID [GADAL LABORATORIES INC]	1
HOREHOUND	INACTIVE INGREDIENT	K08036XEJV	BRONCOMAR SF (GUAIFENESIN) LIQUID [GADAL LABORATORIES INC]	1
LICORICE	INACTIVE INGREDIENT	61ZBX54883	BRONCOMAR SF (GUAIFENESIN) LIQUID [GADAL LABORATORIES INC]	1
MENTHOL	INACTIVE INGREDIENT	L7T10EIP3A	BRONCOMAR SF (GUAIFENESIN) LIQUID [GADAL LABORATORIES INC]	1
MULLEIN LEAF	INACTIVE INGREDIENT	9936O846LI	BRONCOMAR SF (GUAIFENESIN) LIQUID [GADAL LABORATORIES INC]	1
MYRRH	INACTIVE INGREDIENT	JC71GJ1F3L	BRONCOMAR SF (GUAIFENESIN) LIQUID [GADAL LABORATORIES INC]	1
POTASSIUM SORBATE	INACTIVE INGREDIENT	1VPU26JZZ4	BRONCOMAR SF (GUAIFENESIN) LIQUID [GADAL LABORATORIES INC]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	BRONCOMAR SF (GUAIFENESIN) LIQUID [GADAL LABORATORIES INC]	1
PRUNUS SEROTINA BARK	INACTIVE INGREDIENT	5D48E975HA	BRONCOMAR SF (GUAIFENESIN) LIQUID [GADAL LABORATORIES INC]	1
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	BRONCOMAR SF (GUAIFENESIN) LIQUID [GADAL LABORATORIES INC]	1
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	BRONCOMAR SF (GUAIFENESIN) LIQUID [GADAL LABORATORIES INC]	1
SUCRALOSE	INACTIVE INGREDIENT	96K6UQ3ZD4	BRONCOMAR SF (GUAIFENESIN) LIQUID [GADAL LABORATORIES INC]	1
ULMUS RUBRA BARK	INACTIVE INGREDIENT	91QY4PXU8Q	BRONCOMAR SF (GUAIFENESIN) LIQUID [GADAL LABORATORIES INC]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	BRONCOMAR SF (GUAIFENESIN) LIQUID [GADAL LABORATORIES INC]	1
ZINC SULFATE	INACTIVE INGREDIENT	89DS0H96TB	BRONCOMAR SF (GUAIFENESIN) LIQUID [GADAL LABORATORIES INC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53113-218	BRONCOMAR SF (GUAIFENESIN) LIQUID [GADAL LABORATORIES INC]	1	Legacy NDC, 2 package rows	20140613_01bae271-502b-4345-b114-0072c39b4dba.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
495W7451VQ	GUAIFENESIN	93-14-1	GUAIFENESIN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1540024	Broncomar SF Expectorant 100 MG in 5 mL Oral Solution	PSN	01bae271-502b-4345-b114-0072c39b4dba	1
310604	guaiFENesin 100 MG in 5 mL Oral Solution	PSN	01bae271-502b-4345-b114-0072c39b4dba	1
1540024	guaifenesin 20 MG/ML Oral Solution [Broncomar Expectorant]	SBD	01bae271-502b-4345-b114-0072c39b4dba	1
310604	guaifenesin 20 MG/ML Oral Solution	SCD	01bae271-502b-4345-b114-0072c39b4dba	1
1540024	Broncomar SF Expectorant 100 MG per 5 ML Oral Solution	SY	01bae271-502b-4345-b114-0072c39b4dba	1
310604	guaifenesin 100 MG per 5 ML Oral Solution	SY	01bae271-502b-4345-b114-0072c39b4dba	1
310604	guaifenesin 100 MG per 5 ML Oral Syrup	SY	01bae271-502b-4345-b114-0072c39b4dba	1
310604	guaifenesin 200 MG per 10 ML Oral Solution	SY	01bae271-502b-4345-b114-0072c39b4dba	1
310604	guaifenesin 300 MG per 15 ML Oral Solution	SY	01bae271-502b-4345-b114-0072c39b4dba	1
310604	guaifenesin 400 MG per 20 ML Oral Solution	SY	01bae271-502b-4345-b114-0072c39b4dba	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
53113-218-06	53113021806	177 mL in 1 BOTTLE	177 ml	Historical