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
2027-12-31
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
2027-12-31

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 55 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Allergy Relief Extra StrengthDIPHENHYDRAMINE HCLCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED4f33c1fb-150b-4083-a9a4-c0fbab4b61332026-01-27WarningsExact identifier
application number: M012
Cold and Flu Daytime SevereACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLMeijer Distribution Inc5ca7dc60-af0c-47c6-b453-8b39c744eb5b2026-01-27WarningsExact identifier
application number: M012
Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEHyVee Inc2ce5f2af-cabc-466f-b0c5-256e6e6d4c882026-01-27WarningsExact identifier
application number: M012
Sinus Headache and Pain Day, Non-drowsyACETAMINOPHEN, PHENYLEPHRINE HCLARMY AND AIR FORCE EXCHANGE SERVICEc33340c0-47d3-45e2-997b-3d9fb148900f2026-01-27WarningsExact identifier
application number: M012
Cold and Flu Daytime SevereACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLL.N.K. International, Inc.b7501b59-d25a-49ec-9cbf-47018bce83972026-01-27WarningsExact identifier
application number: M012
good sense nighttimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEL. Perrigo Companyf90bd64a-dd1a-4319-87cd-427d57f677ab2026-01-26WarningsExact identifier
application number: M012
Equate Health Non Drowsy DAY Cold and Flu Plus and NIGHTTIME Cold and Flu PlusACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEWal-Mart Stores Inc547ff880-3d40-4a4a-84ee-cd0d5290a9b92026-01-26WarningsExact identifier
application number: M012
Maximum Strength Non Drowsy Day and Night Cold and FluMAXIMUM STRENGTH NON DROWSY DAY AND NIGHT COLD AND FLUWAL-MART STORES INCd6a35fb8-1899-4da2-ad2b-0423e332845d2026-01-26WarningsExact identifier
application number: M012
MUCUS RELIEFGUAIFENESINProdose, Inc.7e5de5b0-18f0-4807-8686-da9821f918ce2026-01-26WarningsExact identifier
application number: M012
ALLERGY RELIEFDIPHENHYDRAMINE HYDROCHLORIDEWal-Mart Stores Incb9fbf917-12b7-770f-e053-2995a90afe932026-01-26WarningsExact identifier
application number: M012
Maximum Strength Non Drowsy Daytime Severe Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEWal-Mart Stores Incb58b2c36-a403-4dae-b3b2-f0ffd28a963b2026-01-26WarningsExact identifier
application number: M012
Allergy Relief Dye FreeDIPHENHYDRAMINE HCLWal-Mart Stores Inc870e6bcb-84ab-45e0-ae57-08a9a182eb0b2026-01-26WarningsExact identifier
application number: M012
Allergy Relief Dye FreeDIPHENHYDRAMINE HCLWal-Mart Stores Inceb8e83a4-981b-48a5-88f4-3a0ba358d3bc2026-01-26WarningsExact identifier
application number: M012
NIGHTTIME SEVERE COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, AND PHENYLEPHRINE HYDROCHLORIDEWal-Mart Stores Inc8d2d765f-a7e3-40e6-b35d-0e8806a7ea592026-01-26WarningsExact identifier
application number: M012
NIGHTTIME COLD AND FLU CHERRYPHENYLEPHRINE, DEXTROMETHORPHAN HYDROBROMIDE, ACETAMINOPHEN, DOXYLAMINE SUCCINATEWalgreen Company02a6781c-aa6f-8fb0-e063-6294a90a043d2026-01-26WarningsExact identifier
application number: M012
Nighttime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN, DOXYLAMINE SUCCINATEWalgreen Company02e5f475-4e9f-2856-e063-6294a90a21fd2026-01-26WarningsExact identifier
application number: M012
GNP Vapor Steam camphor (synthetic)CAMPHOR (SYNTHETIC)AmerisourceBergen0bcc55bf-9654-120b-e063-6394a90a59d12026-01-26WarningsExact identifier
application number: M012
S2RACEPINEPHRINE HYDROCHLORIDENephron Pharmaceuticals Corporationdd1b35c7-b23b-4b95-8162-df3d263fe32e2026-01-26WarningsExact identifier
application number: M012
SEVERE COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDECVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED0d97c634-0975-42d5-8ade-2ed2018cfe9d2026-01-26WarningsExact identifier
application number: M012
GOOD SENSE NIGHT TIMEACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEL. Perrigo Companycd68289b-3850-40c6-9439-aae0e2d7637d2026-01-26WarningsExact 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