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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53113-218-062019-11-27C16284748780-19855e2a2-33d2-60a7-e053-dbdaa90a05bd01bae271-502b-4345-b114-0072c39b4dba

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53113-218-06BroncomarSF177 mL in 1 BOTTLELIQUID1771
53113-218-06BroncomarSF1 in 1 CARTONLIQUID11

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GUAIFENESINACTIVE INGREDIENT495W7451VQBRONCOMAR SF (GUAIFENESIN) LIQUID [GADAL LABORATORIES INC]1
GUAIFENESINACTIVE MOIETY495W7451VQBRONCOMAR SF (GUAIFENESIN) LIQUID [GADAL LABORATORIES INC]1
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLBRONCOMAR SF (GUAIFENESIN) LIQUID [GADAL LABORATORIES INC]1
CAULOPHYLLUM THALICTROIDES ROOTINACTIVE INGREDIENTJTJ6HH6YEHBRONCOMAR SF (GUAIFENESIN) LIQUID [GADAL LABORATORIES INC]1
ECHINACEA, UNSPECIFIEDINACTIVE INGREDIENT4N9P6CC1DXBRONCOMAR SF (GUAIFENESIN) LIQUID [GADAL LABORATORIES INC]1
EUCALYPTUS CAMALDULENSIS LEAF OILINACTIVE INGREDIENTSN6D1J15I6BRONCOMAR SF (GUAIFENESIN) LIQUID [GADAL LABORATORIES INC]1
GINKGO BILOBA WHOLEINACTIVE INGREDIENT660486U6OIBRONCOMAR SF (GUAIFENESIN) LIQUID [GADAL LABORATORIES INC]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXBRONCOMAR SF (GUAIFENESIN) LIQUID [GADAL LABORATORIES INC]1
GOLDENSEALINACTIVE INGREDIENTZW3Z11D0JVBRONCOMAR SF (GUAIFENESIN) LIQUID [GADAL LABORATORIES INC]1
HOREHOUNDINACTIVE INGREDIENTK08036XEJVBRONCOMAR SF (GUAIFENESIN) LIQUID [GADAL LABORATORIES INC]1
LICORICEINACTIVE INGREDIENT61ZBX54883BRONCOMAR SF (GUAIFENESIN) LIQUID [GADAL LABORATORIES INC]1
MENTHOLINACTIVE INGREDIENTL7T10EIP3ABRONCOMAR SF (GUAIFENESIN) LIQUID [GADAL LABORATORIES INC]1
MULLEIN LEAFINACTIVE INGREDIENT9936O846LIBRONCOMAR SF (GUAIFENESIN) LIQUID [GADAL LABORATORIES INC]1
MYRRHINACTIVE INGREDIENTJC71GJ1F3LBRONCOMAR SF (GUAIFENESIN) LIQUID [GADAL LABORATORIES INC]1
POTASSIUM SORBATEINACTIVE INGREDIENT1VPU26JZZ4BRONCOMAR SF (GUAIFENESIN) LIQUID [GADAL LABORATORIES INC]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3BRONCOMAR SF (GUAIFENESIN) LIQUID [GADAL LABORATORIES INC]1
PRUNUS SEROTINA BARKINACTIVE INGREDIENT5D48E975HABRONCOMAR SF (GUAIFENESIN) LIQUID [GADAL LABORATORIES INC]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUBRONCOMAR SF (GUAIFENESIN) LIQUID [GADAL LABORATORIES INC]1
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XBRONCOMAR SF (GUAIFENESIN) LIQUID [GADAL LABORATORIES INC]1
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD4BRONCOMAR SF (GUAIFENESIN) LIQUID [GADAL LABORATORIES INC]1
ULMUS RUBRA BARKINACTIVE INGREDIENT91QY4PXU8QBRONCOMAR SF (GUAIFENESIN) LIQUID [GADAL LABORATORIES INC]1
WATERINACTIVE INGREDIENT059QF0KO0RBRONCOMAR SF (GUAIFENESIN) LIQUID [GADAL LABORATORIES INC]1
ZINC SULFATEINACTIVE INGREDIENT89DS0H96TBBRONCOMAR SF (GUAIFENESIN) LIQUID [GADAL LABORATORIES INC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53113-218BRONCOMAR SF (GUAIFENESIN) LIQUID [GADAL LABORATORIES INC]1Legacy NDC, 2 package rows20140613_01bae271-502b-4345-b114-0072c39b4dba.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1540024Broncomar SF Expectorant 100 MG in 5 mL Oral SolutionPSN01bae271-502b-4345-b114-0072c39b4dba1
310604guaiFENesin 100 MG in 5 mL Oral SolutionPSN01bae271-502b-4345-b114-0072c39b4dba1
1540024guaifenesin 20 MG/ML Oral Solution [Broncomar Expectorant]SBD01bae271-502b-4345-b114-0072c39b4dba1
310604guaifenesin 20 MG/ML Oral SolutionSCD01bae271-502b-4345-b114-0072c39b4dba1
1540024Broncomar SF Expectorant 100 MG per 5 ML Oral SolutionSY01bae271-502b-4345-b114-0072c39b4dba1
310604guaifenesin 100 MG per 5 ML Oral SolutionSY01bae271-502b-4345-b114-0072c39b4dba1
310604guaifenesin 100 MG per 5 ML Oral SyrupSY01bae271-502b-4345-b114-0072c39b4dba1
310604guaifenesin 200 MG per 10 ML Oral SolutionSY01bae271-502b-4345-b114-0072c39b4dba1
310604guaifenesin 300 MG per 15 ML Oral SolutionSY01bae271-502b-4345-b114-0072c39b4dba1
310604guaifenesin 400 MG per 20 ML Oral SolutionSY01bae271-502b-4345-b114-0072c39b4dba1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
53113-218-0653113021806177 mL in 1 BOTTLE177 mlHistorical