FDA.reportPublic FDA data

Cosedal Drops

Product NDC
53145-059
11-digit product format
531450059
Labeler code
53145
Product ID
53145-059_3a8a3022-d085-1ccf-e063-6394a90a90ed
Type
HUMAN OTC DRUG
Nonproprietary name
Dextromethorphan HBR, Guaifenesin
Dosage form
LIQUID
Route
ORAL
Labeler
Menper Distributors, Inc.
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2012-02-21
Substance
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Active strength
10; 100 mg/5mL; mg/5mL
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 · 6 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2020-12-18 03:04 UTC · source 2020-12-17excluded productproductIInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage53145-059-02IInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproductIInactivated by FDA9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage53145-059-02IInactivated by FDA9bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproductEExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage53145-059-02EExcluded after deficient or non-compliant submission was not corrected110d247fa046…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
Cosedal Drops
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXTROMETHORPHAN HYDROBROMIDE10 mg/5mL
GUAIFENESIN100 mg/5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
9D2RTI9KYHInternal UNII lookup
495W7451VQInternal 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
1241d249-ea3b-4d2b-87ed-835d6a2d286aAvailable 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
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53145-059-022023-07-28C16284748780-19d75b9d1-075f-f424-e053-dadaa90a57ceCosedal Drops
53145-059-022021-08-09C16284748780-19d75b9d1-075f-f424-e053-dadaa90a57ceCosedal Drops
53145-059-022020-01-31C16284748780-19d75b9d1-075f-f424-e053-dadaa90a57ceCosedal Drops

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53145-059-02Cosedal Drops60 mL in 1 BOTTLE, DROPPERLIQUID606
53145-059-02Cosedal Drops1 in 1 CARTONLIQUID16

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYHCOSEDAL DROPS (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [MENPER DISTRIBUTORS, INC.]3
GUAIFENESINACTIVE INGREDIENT495W7451VQCOSEDAL DROPS (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [MENPER DISTRIBUTORS, INC.]3
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSCOSEDAL DROPS (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [MENPER DISTRIBUTORS, INC.]3
GUAIFENESINACTIVE MOIETY495W7451VQCOSEDAL DROPS (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [MENPER DISTRIBUTORS, INC.]3
CITRIC ACID ACETATEINACTIVE INGREDIENTDSO12WL7AUCOSEDAL DROPS (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [MENPER DISTRIBUTORS, INC.]3
D&C RED NO. 33INACTIVE INGREDIENT9DBA0SBB0LCOSEDAL DROPS (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [MENPER DISTRIBUTORS, INC.]3
GLYCERININACTIVE INGREDIENTPDC6A3C0OXCOSEDAL DROPS (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [MENPER DISTRIBUTORS, INC.]3
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TCOSEDAL DROPS (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [MENPER DISTRIBUTORS, INC.]3
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3COSEDAL DROPS (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [MENPER DISTRIBUTORS, INC.]3
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHCOSEDAL DROPS (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [MENPER DISTRIBUTORS, INC.]3
RASPBERRYINACTIVE INGREDIENT4N14V5R27WCOSEDAL DROPS (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [MENPER DISTRIBUTORS, INC.]3
SUCROSEINACTIVE INGREDIENTC151H8M554COSEDAL DROPS (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [MENPER DISTRIBUTORS, INC.]3
WATERINACTIVE INGREDIENT059QF0KO0RCOSEDAL DROPS (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [MENPER DISTRIBUTORS, INC.]3

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 164 of 195 · 3,895 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Allergy Multi-SymptomACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE HYDROCHLORIDESTRATEGIC SOURCING SERVICES LLC38e70a28-eff2-4a48-b829-8cd68e80beef2024-10-17WarningsExact identifier
application number: M012
Mucus Relief XpectGUAIFENSIN, DEXTROMETHORPHANMidway Importing Inc.c2c8bd26-bbf1-c2e6-e053-2995a90a86a72024-10-17WarningsExact identifier
application number: M012
Antiflu Des Cough and FluACETAMINOPHEN PHENYLEPHRINE HCL CHLORPHENIRAMINE MALEATEProductos Farmaceuticos, S.A. de C.V.dcf3897a-a793-6df7-e053-2995a90a25f82024-10-17WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDEFSA STORE INC.ec6aef90-ece1-4fe6-e053-2995a90a93102024-10-16WarningsExact identifier
application number: M012
Tukol MAX ACTION Cold, Sore Throat and CoughACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLGenomma Lab USA, Incc8eebe64-00bf-436d-a9fc-1623401bebfa2024-10-16WarningsExact identifier
application number: M012
AllergyDIPHENHYDRAMINE HYDROCHLORIDEDiscount Drug Mart4f42c8d2-0538-4bcd-aac0-e26103a304992024-10-16WarningsExact identifier
application number: M012
Tukol MAX ACTION Severe Congestion and CoughDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLGenomma Lab USA, Inc9ac3e24a-d18a-48fc-8005-55393085d57b2024-10-16WarningsExact identifier
application number: M012
Nighttime CoughDEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATECVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED45471fdd-c4cd-46ad-a932-aa37327e8a412024-10-16WarningsExact identifier
application number: M012
DG Health Cold and Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEDolgencorp Inc8cb15a8d-c836-4167-bc6b-dd20a34076e82024-10-16WarningsExact identifier
application number: M012
basic care nighttime cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEAmazon.com Services LLCf4497e56-c69d-4ae9-bd81-80bf2ee1b17f2024-10-15WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDEFOODHOLD U.S.A., LLC8256c1fb-683d-56ab-e053-2a91aa0ac1972024-10-15WarningsExact identifier
application number: M012
SINUS SEVREACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDERETAIL BUSINESS SERVICES , LLC.9f9586e3-a8b4-4060-e053-2995a90aa0682024-10-15WarningsExact identifier
application number: M012
ALLERGY RELIEFDIPHENHYDRAMINE HYDROCHLORIDERETAIL BUSINESS SERVICES , LLC.9f95715f-63dc-6086-e053-2a95a90adb0c2024-10-15WarningsExact identifier
application number: M012
Allergy MultiSymptomACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE HYDROCHLORIDERETAIL BUSINESS SERVICES , LLC.a61636e9-8fe2-8419-e053-2a95a90a011c2024-10-15WarningsExact identifier
application number: M012
SINUS AND HEADACHEACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDERETAIL BUSINESS SERVICES , LLC.9f95b2e8-dea4-ef59-e053-2a95a90a0bcb2024-10-15WarningsExact identifier
application number: M012
Cold Multi-Symptom DaytimeACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDEAmerican Sales Companyd2dcbc7c-e66c-4922-83df-c706a37bf3342024-10-15WarningsExact identifier
application number: M012
Cold and Flu SevereACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDERETAIL BUSINESS SERVICES , LLC. (9f958d97-8dcf-332d-e053-2995a90a0a652024-10-15WarningsExact identifier
application number: M012
Severe Congestion and PainACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDERetail Business Services , LLC.8bc68a71-62c5-a04f-e053-2995a90a92fd2024-10-15WarningsExact identifier
application number: M012
COLD FLU AND SORE THROATACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDERETAIL BUSINESS SERVICES , LLC.9f960566-0158-6637-e053-2995a90a9c4a2024-10-15WarningsExact identifier
application number: M012
HEAD CONGESTION PLUS FLU SEVERE PEACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDERETAIL BUSINESS SERVICES , LLC.e65cf21d-3d69-a53e-e053-2a95a90a1c832024-10-15WarningsExact 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 SolutionPSN1241d249-ea3b-4d2b-87ed-835d6a2d286a6
996520dextromethorphan hydrobromide 2 MG/ML / guaifenesin 20 MG/ML Oral SolutionSCD1241d249-ea3b-4d2b-87ed-835d6a2d286a6
996520dextromethorphan hydrobromide 10 MG / guaifenesin 100 MG per 5 ML Oral SolutionSY1241d249-ea3b-4d2b-87ed-835d6a2d286a6
996520dextromethorphan hydrobromide 15 MG / guaifenesin 150 MG per 7.5 ML Oral SolutionSY1241d249-ea3b-4d2b-87ed-835d6a2d286a6
996520dextromethorphan hydrobromide 20 MG / guaifenesin 200 MG per 10 ML Oral SolutionSY1241d249-ea3b-4d2b-87ed-835d6a2d286a6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
53145-059-02531450059021 BOTTLE, DROPPER in 1 CARTON (53145-059-02) / 60 mL in 1 BOTTLE, DROPPER2012-02-210000-00-00NoNoCurrent