FDA.reportPublic FDA data

Defensol Adult Syrup

Product NDC
53145-039
11-digit product format
531450039
Labeler code
53145
Product ID
53145-039_3a89a0df-993d-f0d7-e063-6394a90a1c8b
Type
HUMAN OTC DRUG
Nonproprietary name
Guaifenesin, Dextromethorphan HBR
Dosage form
LIQUID
Route
ORAL
Labeler
Menper Distributors, Inc.
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2012-02-21
Substance
GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE
Active strength
200; 20 mg/10mL; mg/10mL
Pharmacologic classes
Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2019-12-08 06:16 UTC · source 2019-12-05excluded productproduct53145-039EExcluded after deficient or non-compliant submission was not correctedexcluded / ndc_excluded.zip110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage53145-03953145-039-04EExcluded after deficient or non-compliant submission was not correctedexcluded / ndc_excluded.zip110d247fa046…a55b01930146…

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
Defensol Adult Syrup
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GUAIFENESIN200 mg/10mL
DEXTROMETHORPHAN HYDROBROMIDE20 mg/10mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
495W7451VQInternal UNII lookup
9D2RTI9KYHInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
996520Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
62acff69-8c40-4a0e-8d56-be2cc14e3d45Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
EffectiveRelated label
2023-07-28Defensol Adult Syrup
2022-02-18Defensol Adult Syrup
2022-01-28Defensol Adult Syrup
2020-02-04Defensol Adult Syrup
2020-01-31Defensol Adult Syrup

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53145-039-04Defensol Adult Syrup1 in 1 CARTONLIQUID16
53145-039-04Defensol Adult Syrup120 mL in 1 BOTTLELIQUID1206

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYHDEFENSOL ADULT SYRUP (GUAIFENESIN, DEXTROMETHORPHAN HBR) LIQUID [MENPER DISTRIBUTORS, INC.]2
GUAIFENESINACTIVE INGREDIENT495W7451VQDEFENSOL ADULT SYRUP (GUAIFENESIN, DEXTROMETHORPHAN HBR) LIQUID [MENPER DISTRIBUTORS, INC.]2
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSDEFENSOL ADULT SYRUP (GUAIFENESIN, DEXTROMETHORPHAN HBR) LIQUID [MENPER DISTRIBUTORS, INC.]2
GUAIFENESINACTIVE MOIETY495W7451VQDEFENSOL ADULT SYRUP (GUAIFENESIN, DEXTROMETHORPHAN HBR) LIQUID [MENPER DISTRIBUTORS, INC.]2
CITRIC ACID ACETATEINACTIVE INGREDIENTDSO12WL7AUDEFENSOL ADULT SYRUP (GUAIFENESIN, DEXTROMETHORPHAN HBR) LIQUID [MENPER DISTRIBUTORS, INC.]2
D&C RED NO. 33INACTIVE INGREDIENT9DBA0SBB0LDEFENSOL ADULT SYRUP (GUAIFENESIN, DEXTROMETHORPHAN HBR) LIQUID [MENPER DISTRIBUTORS, INC.]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXDEFENSOL ADULT SYRUP (GUAIFENESIN, DEXTROMETHORPHAN HBR) LIQUID [MENPER DISTRIBUTORS, INC.]2
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TDEFENSOL ADULT SYRUP (GUAIFENESIN, DEXTROMETHORPHAN HBR) LIQUID [MENPER DISTRIBUTORS, INC.]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3DEFENSOL ADULT SYRUP (GUAIFENESIN, DEXTROMETHORPHAN HBR) LIQUID [MENPER DISTRIBUTORS, INC.]2
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHDEFENSOL ADULT SYRUP (GUAIFENESIN, DEXTROMETHORPHAN HBR) LIQUID [MENPER DISTRIBUTORS, INC.]2
RASPBERRYINACTIVE INGREDIENT4N14V5R27WDEFENSOL ADULT SYRUP (GUAIFENESIN, DEXTROMETHORPHAN HBR) LIQUID [MENPER DISTRIBUTORS, INC.]2
SUCROSEINACTIVE INGREDIENTC151H8M554DEFENSOL ADULT SYRUP (GUAIFENESIN, DEXTROMETHORPHAN HBR) LIQUID [MENPER DISTRIBUTORS, INC.]2
WATERINACTIVE INGREDIENT059QF0KO0RDEFENSOL ADULT SYRUP (GUAIFENESIN, DEXTROMETHORPHAN HBR) LIQUID [MENPER DISTRIBUTORS, INC.]2

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 38 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Vicks Sinex Severe OriginalOXYMETAZOLINE HYDROCHLORIDEProcter & Gamble Manufacturing GmbHcfd048c9-2f33-101d-e053-2995a90ad8542026-04-22WarningsExact identifier
application number: M012
Vicks Sinex SEVERE VapoCOOL ULTRA FINE MISTOXYMETAZOLINE HYDROCHLORIDEProcter & Gamble Manufacturing GmbHd0768332-7c24-7c30-e053-2a95a90a26d42026-04-22WarningsExact identifier
application number: M012
HistanazPSEUDOEPHEDRINE HCL, PYRILAMINE MALEATECapital Pharmaceutical, LLC3e87d0f3-f16c-5972-e063-6294a90acc8a2026-04-22WarningsExact identifier
application number: M012
Good Sense Severe Daytime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLL. Perrigo Companyd5faf89f-3641-4be1-8d43-35504f12fe8d2026-04-22WarningsExact identifier
application number: M012
Multi-Symptom Cold childrensDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLWALMART INC.5ee5eb75-fc56-42a1-bf2c-b9c10ea8bfd42026-04-22WarningsExact identifier
application number: M012
good sense nasalOXYMETAZOLINE HYDROCHLORIDEL. Perrigo Company95f23049-e523-4c59-904c-b8e9ae82602c2026-04-22WarningsExact identifier
application number: M012
Mucinex Childrens FreeFrom Multi-Symptom Cold and Stuffy NoseDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEReckitt Benckiser LLCc07dad99-87b0-419b-9230-7c22a77ecf9e2026-04-21WarningsExact identifier
application number: M012
Cough and Cold HBPCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBRValu Merchandisers Company83db90da-9155-4f6a-8209-44c87d14b6962026-04-21WarningsExact identifier
application number: M012
Pain, Headache and CoughACETAMINOPHEN, DEXTROMETHORPHAN HBRCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED613a2516-fc61-4bb4-bd44-ca60045481932026-04-21WarningsExact identifier
application number: M012
Dr. Simi Allergy ReliefDIPHENHYDRAMINE HCLFarmacias De Similares TX LLC4fe8bbe3-13c9-5458-e063-6294a90a90642026-04-20WarningsExact identifier
application number: M012
Cold and Flu Day and Night, SevereACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLARMY AND AIR FORCE EXCHANGE SERVICE58d722ef-db67-44ac-a295-dd10e1f5ca1d2026-04-20WarningsExact identifier
application number: M012
Loratadine 10mgLORATADINEBETTER LIVING BRANDS, LLC46d615dd-45d5-2dfc-e063-6394a90a5d422026-04-18WarningsExact identifier
application number: M012
Multi-Symptom Cold DaytimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLValu Merchandisers Companyd0f896a6-5637-45ef-bf60-b343cbcdcf7e2026-04-17WarningsExact identifier
application number: M012
MUCUS RELIEFGUAIFENESINBryant Ranch Prepack9ed5611f-4e1d-4f71-b430-a2a949bf7fe52026-04-17WarningsExact identifier
application number: M012
Multi-Symptom ColdACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLValu Merchandisers Companybf3158af-89ab-4b7c-9f39-0f316fbe90562026-04-17WarningsExact identifier
application number: M012
MUCUS RELIEFGUAIFENESINBryant Ranch Prepack761825bc-f835-4947-bfa0-2940f1dff5fb2026-04-17WarningsExact identifier
application number: M012
equate cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEWALMART INC.e83d14cc-9b90-40ce-a00a-2702d8a8968f2026-04-17WarningsExact identifier
application number: M012
Childrens Allergy ReliefDIPHENHYDRAMINE HCLWalgreen Company0b34b5a3-98a2-4096-9d95-071bb5a63c862026-04-17WarningsExact identifier
application number: M012
Mucus ReliefGUAIFENESINWalgreen Company1cd69ede-29c6-4216-95b7-b58fc96c084b2026-04-16WarningsExact identifier
application number: M012
Sinus SevereACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCLValu Merchandisers Companycdcb8e0d-7847-4f28-bb09-7dc7b5d35c132026-04-16WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
996520dextromethorphan HBr 20 MG / guaiFENesin 200 MG in 10 mL Oral SolutionPSN62acff69-8c40-4a0e-8d56-be2cc14e3d456
996520dextromethorphan hydrobromide 2 MG/ML / guaifenesin 20 MG/ML Oral SolutionSCD62acff69-8c40-4a0e-8d56-be2cc14e3d456
996520dextromethorphan hydrobromide 10 MG / guaifenesin 100 MG per 5 ML Oral SolutionSY62acff69-8c40-4a0e-8d56-be2cc14e3d456
996520dextromethorphan hydrobromide 15 MG / guaifenesin 150 MG per 7.5 ML Oral SolutionSY62acff69-8c40-4a0e-8d56-be2cc14e3d456
996520dextromethorphan hydrobromide 20 MG / guaifenesin 200 MG per 10 ML Oral SolutionSY62acff69-8c40-4a0e-8d56-be2cc14e3d456

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53145-039-04531450039041 BOTTLE in 1 CARTON (53145-039-04) / 120 mL in 1 BOTTLE1 bottle2012-02-210000-00-00NoNoCurrent