FDA.reportPublic FDA data

Childrens Giltuss EX Expectorant

Product NDC
65852-016
11-digit product format
658520016
Labeler code
65852
Product ID
65852-016_3f8d7d47-f14d-888c-e063-6394a90a5cdd
Type
HUMAN OTC DRUG
Nonproprietary name
Guaifenesin
Dosage form
SOLUTION
Route
ORAL
Labeler
Dextrum Laboratories Inc.
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-06-22
Substance
GUAIFENESIN
Active strength
200 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

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
Childrens Giltuss EX Expectorant
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GUAIFENESIN200 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
310625Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
3f8d7d47-f14c-888c-e063-6394a90a5cddAvailable 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
65852-016-04Childrens Giltuss EX Expectorant1 in 1 CARTONSOLUTION11
65852-016-04Childrens Giltuss EX Expectorant118 mL in 1 BOTTLE, PLASTICSOLUTION1181

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 150 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tukol Cough and CongestionDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEGenomma Lab USA27ab3d86-e960-4d83-aad1-d50d2c8e02a92024-10-14WarningsExact identifier
application number: M012
HealthWise Chest Rub LavenderCAMPHOR, MENTHOL, EUCALYPTUS OILVeridian Healthcare2472ce85-c701-4fcd-e063-6394a90a27652024-10-14WarningsExact identifier
application number: M012
HealthWise Chest Rub LemonCAMPHOR, MENTHOL, EUCALYPTUS OILVeridian Healthcare24740d5a-aba1-0bd4-e063-6394a90ab2ca2024-10-14WarningsExact identifier
application number: M012
Childrens Plus Cough and Runny NoseACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDEDolgencorp, Inc. (DOLLAR GENERAL & REXALL)ea059b56-dc9a-4a6b-8c16-5dfcdaf4cd432024-10-14WarningsExact identifier
application number: M012
Theraflu Severe Cold ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DIPHENPHYDRAMINE HCL, GUAIFENESINHaleon US Holdings LLCb01cc9f5-53f2-40d8-acf1-6de180b3d0bf2024-10-14WarningsExact identifier
application number: M012
Cough Relief AdultDEXTROMETHORPHAN HBRDolgencorp, Inc. (DOLLAR GENERAL & REXALL)f5c57b32-69cb-469e-ad2d-64c00b5e66dc2024-10-14WarningsExact identifier
application number: M012
Nasal DecongestantPSEUDOEPHEDRINE HCLPublix Super Markets Inc94c21df5-c631-4748-a833-288b2298055c2024-10-12WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDEChain Drug Marketing Association8eab9d79-69c1-44b8-9145-a7ebd887d54d2024-10-11WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDEChain Drug Marketing Associatione4963eec-fb4a-425c-be19-f514b4f10a7f2024-10-11WarningsExact identifier
application number: M012
Severe Sinus Congestion and PainACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEChain Drug Marketing Association1b4e87f8-3f9e-4865-9128-527d2d6215932024-10-11WarningsExact identifier
application number: M012
Mucus Relief Cold and Flu All in OneACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDECHAIN DRUG MARKETING ASSOCIATION INCff433512-55b7-4fc9-8a55-aff5cbb749ef2024-10-11WarningsExact identifier
application number: M012
Mucus Relief Cold Flu and Sore ThroatACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDECHAIN DRUG MARKETING ASSOCIATION INC3170354a-4752-49a0-97ed-3d9db266a0592024-10-11WarningsExact identifier
application number: M012
Tukol Children Cough and CongestionDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEGenomma Lab USA235a6d2b-7302-410c-be35-4d5ff7bbdfce2024-10-11WarningsExact identifier
application number: M012
Night Time Cold and Flu Relief Multi SymptomACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATECVS Pharmacy6c7b0ea6-bff9-4fd2-9e00-64015c326ee82024-10-11WarningsExact identifier
application number: M012
nitetime cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEMeijer Distribution Incdcc12bc2-4bb4-4d2d-8206-b9db9843ec8b2024-10-11WarningsExact identifier
application number: M012
Signature Care Nasal DecongestantOXYMETAZOLINE HYDROCHLORIDESafeway838d2f11-2ee4-4081-98c8-b87e79aa47c42024-10-11WarningsExact identifier
application number: M012
MentholCOUGH SUPPRESSANTMcKesson9d4def70-480f-f2fa-e053-2995a90a98772024-10-10WarningsExact identifier
application number: M012
MentholCOUGH SUPPRESSANTMcKesson9d5b4ef6-4eb8-41f6-e053-2a95a90a13502024-10-10WarningsExact identifier
application number: M012
Tukol Sugar Free Cough and ColdDEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESINGenomma Lab USA95e0a3eb-5a58-4c8b-a70b-fb0cca1e08412024-10-08WarningsExact identifier
application number: M012
Rompe Pecho CF CFBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBREfficient Laboratories Inc06e96e0c-f21f-e706-e063-6294a90a07802024-10-08WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310625guaiFENesin 200 MG in 5 mL Oral SolutionPSN3f8d7d47-f14c-888c-e063-6394a90a5cdd1
310625guaifenesin 40 MG/ML Oral SolutionSCD3f8d7d47-f14c-888c-e063-6394a90a5cdd1
310625guaifenesin 200 MG per 5 ML Oral SolutionSY3f8d7d47-f14c-888c-e063-6394a90a5cdd1
310625guaifenesin 400 MG per 10 ML Oral SolutionSY3f8d7d47-f14c-888c-e063-6394a90a5cdd1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
65852-016-04658520016041 BOTTLE, PLASTIC in 1 CARTON (65852-016-04) / 118 mL in 1 BOTTLE, PLASTIC2020-06-22NoNoCurrent