ED BRON GP

Product NDC
0485-0208
11-digit product format
004850208
Labeler code
0485
Product ID
0485-0208_423e6598-ff90-d9d4-e063-6294a90a1fba
Type
HUMAN OTC DRUG
Nonproprietary name
GUAIFENESIN and PHENYLEPHRINE
Dosage form
LIQUID
Route
ORAL
Labeler
EDWARDS PHARMACEUTICALS, INC.
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2012-06-01
Substance
GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active strength
100; 5 mg/5mL; mg/5mL
Pharmacologic classes
Adrenergic alpha1-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], alpha-1 Adrenergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
ED BRON GP
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GUAIFENESIN100 mg/5mL
PHENYLEPHRINE HYDROCHLORIDE5 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii495W7451VQ, 04JA59TNSJ
Rxcui1358627

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e4e263da-1c53-440f-bb80-b7a575843b5aProduct name120260313
d2168cac-a261-415a-9c78-3522859fa720Product name320251124
05a8cdd1-eeb8-409e-b938-0778225eca7dProduct name420250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9Product name820250220
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0485-0208-16ED BRON GP473 mL in 1 BOTTLE, PLASTICLIQUID4739

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0485-0208-16ML - Milliliter0485-02080e9e665e-1ab6-44a9-8e7d-8d4f4a1f8b1d12013-04-01

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GUAIFENESINACTIVE INGREDIENT495W7451VQED BRON GP (GUAIFENESIN AND PHENYLEPHRINE) LIQUID [EDWARDS PHARMACEUTICALS, INC.]1
PHENYLEPHRINEACTIVE INGREDIENT1WS297W6MVED BRON GP (GUAIFENESIN AND PHENYLEPHRINE) LIQUID [EDWARDS PHARMACEUTICALS, INC.]1
GUAIFENESINACTIVE MOIETY495W7451VQED BRON GP (GUAIFENESIN AND PHENYLEPHRINE) LIQUID [EDWARDS PHARMACEUTICALS, INC.]1
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVED BRON GP (GUAIFENESIN AND PHENYLEPHRINE) LIQUID [EDWARDS PHARMACEUTICALS, INC.]1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPED BRON GP (GUAIFENESIN AND PHENYLEPHRINE) LIQUID [EDWARDS PHARMACEUTICALS, INC.]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TED BRON GP (GUAIFENESIN AND PHENYLEPHRINE) LIQUID [EDWARDS PHARMACEUTICALS, INC.]1
POTASSIUM CITRATEINACTIVE INGREDIENTEE90ONI6FFED BRON GP (GUAIFENESIN AND PHENYLEPHRINE) LIQUID [EDWARDS PHARMACEUTICALS, INC.]1
POTASSIUM SORBATEINACTIVE INGREDIENT1VPU26JZZ4ED BRON GP (GUAIFENESIN AND PHENYLEPHRINE) LIQUID [EDWARDS PHARMACEUTICALS, INC.]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3ED BRON GP (GUAIFENESIN AND PHENYLEPHRINE) LIQUID [EDWARDS PHARMACEUTICALS, INC.]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHED BRON GP (GUAIFENESIN AND PHENYLEPHRINE) LIQUID [EDWARDS PHARMACEUTICALS, INC.]1
SORBITOLINACTIVE INGREDIENT506T60A25RED BRON GP (GUAIFENESIN AND PHENYLEPHRINE) LIQUID [EDWARDS PHARMACEUTICALS, INC.]1
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD4ED BRON GP (GUAIFENESIN AND PHENYLEPHRINE) LIQUID [EDWARDS PHARMACEUTICALS, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RED BRON GP (GUAIFENESIN AND PHENYLEPHRINE) LIQUID [EDWARDS PHARMACEUTICALS, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0485-0208ED BRON GP (GUAIFENESIN AND PHENYLEPHRINE) LIQUID [EDWARDS PHARMACEUTICALS, INC.]8Current NDC, Legacy NDC, 1 package rows20241228_b1fca5aa-d877-45e0-b074-dcbc6af94ee3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1358627guaiFENesin 100 MG / phenylephrine HCl 5 MG in 5 mL Oral SolutionPSNb1fca5aa-d877-45e0-b074-dcbc6af94ee39
1358627guaifenesin 20 MG/ML / phenylephrine hydrochloride 1 MG/ML Oral SolutionSCDb1fca5aa-d877-45e0-b074-dcbc6af94ee39
1358627guaifenesin 100 MG / phenylephrine hydrochloride 5 MG per 5 ML Oral SolutionSYb1fca5aa-d877-45e0-b074-dcbc6af94ee39

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0485-0208-1600485020816473 mL in 1 BOTTLE, PLASTIC (0485-0208-16) 473 ml2012-06-010000-00-00NoNoCurrent