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 97 of 195 · 3,893 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Menthol Drops Dollar General Severe 45ctMENTHOLDollar General Corporationc831d3d9-b910-40e6-bfdf-defe6850614d2025-10-24WarningsExact identifier
application number: M012
Cough Drops Dollar General Strawberry 30ctMENTHOLDollar General Corporation7d2f3292-bb73-41dc-9729-edb83670be1b2025-10-24WarningsExact identifier
application number: M012
Freegells Cough Drops Menthol 30ctMENTHOLR.L. ALBERT & SON, INCb174e57c-4e4f-4842-b8f2-f1b067764a682025-10-24WarningsExact identifier
application number: M012
Meijer Adult Severe Multi-Symptom Cough Cold FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEMEIJER DISTRIBUTION INC4cc27b78-5e6d-4993-a851-9e6af32620fa2025-10-24WarningsExact identifier
application number: M012
Meijer Nitetime Cold and Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEMEIJER DISTRIBUTION INCf7cc9b50-8199-4df7-97a7-b09358f2931b2025-10-24WarningsExact identifier
application number: M012
Meijer Nighttime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, TRIPROLIDINE HCLMEIJER DISTRIBUTION INC.98bf18b0-b489-4a31-8e1e-fadfd399ee002025-10-24WarningsExact identifier
application number: M012
Meijer Childrens Allergy Relief Bubblegum flavorDIPHENHYDRAMINE HCLMEIJER DISTRIBUTION INCd3f7b0ee-51e8-466f-ad9f-98ac879c330a2025-10-24WarningsExact identifier
application number: M012
Meijer OriginalNASALMEIJER DISTRIBUTION INC61d7db6f-1180-4ed5-9ad4-c98b3964536b2025-10-24WarningsExact identifier
application number: M012
Meijer Maximum Strength Severe Congestion and CoughDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEMEIJER, INC.5d2b54e5-1cb7-4071-9de2-afae33536c492025-10-24WarningsExact identifier
application number: M012
Meijer Mucus Relief DM Maximum StrengthDEXTROMETHORPHAN HBR AND GUAIFENESINMEIJER, INC.12cbe71a-a796-4f14-848e-aa6082dac0322025-10-24WarningsExact identifier
application number: M012
Meijer Adult Mucus Plus chest congestionGUAIFENESINMEIJER DISTRIBUTION, INCf6a23be6-0313-4c23-afb7-576666b80e212025-10-24WarningsExact identifier
application number: M012
Meijer Children Cough and Chest Congestion DM Grape FlavorDEXTROMETHORPHAN HBR AND GUAIFENESINMEIJER DISTRIBUTION INC9121804a-e5eb-46a2-a4a7-cc625be846d12025-10-24WarningsExact identifier
application number: M012
meijer Maximum Strength Nighttime Cough DMDEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEMEIJER DISTRIBUTION INCa99f36b1-6cf4-496e-a347-08aa21cba1632025-10-24WarningsExact identifier
application number: M012
Maximum Strength Mucus Relief Severe Congestion and Cough Cooling MentholDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEMEIJER DISTRIBUTION INCab8322f6-8474-4043-8f2b-a71e3f3b48ce2025-10-24WarningsExact identifier
application number: M012
Daytime Nighttime Severe Cold and Flu ReliefACETAMINOPHEN DEXTROMETHORPHAN HBR GUAIFENESIN PHENYLEPHRINE HCI DOXYLAMINE SUCINATEFamily Dollar (FAMILY WELLNESS)22918db6-9096-4eb8-a742-aaa2dd5c31da2025-10-24WarningsExact identifier
application number: M012
Daytime Sinus SevereACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCLKroger Company1022767d-a456-4fbc-95cf-91337c74c3302025-10-24WarningsExact identifier
application number: M012
Daytime Severe Cold and Flu ReliefACETAMINOPHEN DEXTROMETHORPHAN HBR GUAIFENESIN, PHENYLEPHRINE HCLFamily Dollar (FAMILY WELLNESS)17640528-c1f7-4881-ba86-bb3f488a952c2025-10-24WarningsExact identifier
application number: M012
Vapor StickCAMPHOR/MENTHOLChina Ningbo Shangge Cosmetics Technology Corp.33e259d6-b065-a677-e063-6394a90ab3142025-10-23WarningsExact identifier
application number: M012
Severe Nighttime Severe DaytimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLCVS Pharmacy1ec3fc79-4f38-439f-99be-646b82231aa52025-10-23WarningsExact identifier
application number: M012
daytime nighttime cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLWalgreen Company12fd5713-0ae4-4d6a-bf33-7e3d76e10c782025-10-22WarningsExact 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