FDA.reportPublic FDA data

Guaifenesin STRAWBERRY-BANANA FLAVOR

Product NDC
71800-059
11-digit product format
718000059
Labeler code
71800
Product ID
71800-059_37de006a-e717-a4e5-e063-6394a90abd8b
Type
HUMAN OTC DRUG
Nonproprietary name
GUAIFENESIN
Dosage form
LIQUID
Route
ORAL
Labeler
Innovida Pharmaeutique Corporation
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-06-16
Substance
GUAIFENESIN
Active strength
100 mg/5mL
Pharmacologic classes
Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Guaifenesin STRAWBERRY-BANANA FLAVOR
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GUAIFENESIN100 mg/5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
495W7451VQInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
310604Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1006906e-d6d7-4f49-92bf-3cb2d2cdbb16Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71800-059-19Guaifenesin STRAWBERRY-BANANA FLAVOR119 mL in 1 TUBELIQUID1191

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71800-059-19ML - Milliliter71800-059d3fa3ffd-d057-44a7-b7b8-f8d657a3803c12026-04-20

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 122 of 195 · 3,893 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Herbal Cough DropsHERBAL MENTHOLMeijer, Inc.380364be-4e52-fa52-e063-6394a90a713c2025-06-20WarningsExact identifier
application number: M012
DayQuil Cold and Flu w/VapoCOOL, 4ct (PE-free), BSXACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE TABLET, COATEDLil' Drug Store Products, Inc.37c55543-e05e-2f7c-e063-6394a90a45342025-06-20WarningsExact identifier
application number: M012
Exchange Select Cough Drops Honey Lemon Sugar-FreeMENTHOLXiamen Kang Zhongyuan Biotechnology Co., Ltd.38049d29-f47e-9478-e063-6294a90aa2a42025-06-20WarningsExact identifier
application number: M012
Exchange Select Cough Drops Menthol Sugar FreeMENTHOLXiamen Kang Zhongyuan Biotechnology Co., Ltd.3804a271-9a11-848d-e063-6394a90af87d2025-06-20WarningsExact identifier
application number: M012
Exchange Select Cough Drops Menthol Sugar FreeMENTHOLArmy & Air Force Exchange Service3805ef07-247d-0df7-e063-6394a90ac45b2025-06-20WarningsExact identifier
application number: M012
Exchange Select Cough Drop Black Cherry Sugar FreeMENTHOLArmy & Air Force Exchange Service3805f8f5-562f-0ba8-e063-6394a90ac9d92025-06-20WarningsExact identifier
application number: M012
Exchange Select Cough Drops Honey Lemon Sugar-FreeMENTHOLArmy & Air Force Exchange Service3805f90e-bd89-128d-e063-6394a90afa012025-06-20WarningsExact identifier
application number: M012
TARGET Multi Symptom Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, AND ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBRTARGET CORPORATIONaebe3c15-53ef-46ea-af39-8c9b8114595f2025-06-20WarningsExact identifier
application number: M012
TYLENOL Cold Plus Flu SevereACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEMorning Star OTCbe95332d-a2e0-42e8-bfb3-8850d74990ff2025-06-19WarningsExact identifier
application number: M012
Tylenol Sinus SevereACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEMorning Star OTC37e939c6-064b-3548-e063-6294a90a337d2025-06-19WarningsExact identifier
application number: M012
Capron DMDEXTROMETHORPHAN HBR AND PYRILAMINE MALEATECapital Pharmaceutical, LLCcf778c5f-475e-4a86-a87c-2be1e665f5a52025-06-18WarningsExact identifier
application number: M012
Cough OutGUAIFENESINEfficient Laboratories Inc.fe4c3921-8d30-4cd6-ba90-9211b362a38a2025-06-18WarningsExact identifier
application number: M012
Guaifenesin STRAWBERRY-BANANA FLAVORGUAIFENESINInnovida Pharmaeutique Corporation1006906e-d6d7-4f49-92bf-3cb2d2cdbb162025-06-18WarningsExact identifier
application number: M012
ndc (product): 71800-059
Mucinex Sinus Max Clear and CoolACETAMINOPHEN AND GUAIFENESINRB Health (US) LLC37de813a-54b7-672a-e063-6294a90a374e2025-06-18WarningsExact identifier
application number: M012
childrens cold coughBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDECVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED4a1aeb41-a8fa-4116-8068-e11acd608e582025-06-18WarningsExact identifier
application number: M012
equate childrens cold coughBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDEWALMART INC.24758ab0-ba08-4b4a-9861-449612bdb89c2025-06-18WarningsExact identifier
application number: M012
NyQuil Cold and Flu w/VapoCOOL, 4ct, Travel BASIXACETAMINOPHEN, DOXYLAMINE SUCCINATE, DEXTROMETHORPHAN HYDROBROMIDE TABLET, COATEDLil' Drug Store Products, Inc.37c768f5-dabd-22d0-e063-6394a90af9e52025-06-17WarningsExact identifier
application number: M012
DISCOUNT DRUG MART Childrens Allergy ChewableDIPHENHYDRAMINE HCLDISCOUNT DRUG MART51de95da-e8e8-48f0-9fa4-6191aa4a247b2025-06-16WarningsExact identifier
application number: M012
Halls CherryMENTHOLMondelez Global LLC5f4af8e8-8550-45c7-a199-694efac9e7be2025-06-16WarningsExact identifier
application number: M012
Halls Honey LemonMENTHOLMondelez Global LLC25eaae85-d516-40da-a472-70736ea2b75d2025-06-16WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310604guaiFENesin 100 MG in 5 mL Oral SolutionPSN1006906e-d6d7-4f49-92bf-3cb2d2cdbb161
310604guaifenesin 20 MG/ML Oral SolutionSCD1006906e-d6d7-4f49-92bf-3cb2d2cdbb161
310604guaifenesin 100 MG per 5 ML Oral SolutionSY1006906e-d6d7-4f49-92bf-3cb2d2cdbb161
310604guaifenesin 100 MG per 5 ML Oral SyrupSY1006906e-d6d7-4f49-92bf-3cb2d2cdbb161
310604guaifenesin 200 MG per 10 ML Oral SolutionSY1006906e-d6d7-4f49-92bf-3cb2d2cdbb161
310604guaifenesin 300 MG per 15 ML Oral SolutionSY1006906e-d6d7-4f49-92bf-3cb2d2cdbb161
310604guaifenesin 400 MG per 20 ML Oral SolutionSY1006906e-d6d7-4f49-92bf-3cb2d2cdbb161

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71800-059-1971800005919119 mL in 1 TUBE (71800-059-19) 119 ml2025-06-16NoNoCurrent