FDA.reportPublic FDA data

Bisolvine

Product NDC
53145-402
11-digit product format
531450402
Labeler code
53145
Product ID
53145-402_3a8afea2-5d9f-1392-e063-6294a90aca43
Type
HUMAN OTC DRUG
Nonproprietary name
Dextromethorphan, Guaifenesin
Dosage form
LIQUID
Route
ORAL
Labeler
MENPER DISTRIBUTORS INC.
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-01-01
Substance
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Active strength
10; 100 mg/15mL; mg/15mL
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

Additional Listing Data#

Finished product
Yes
Brand name base
Bisolvine
Brand name suffix
Aloe-Miel
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXTROMETHORPHAN HYDROBROMIDE10 mg/15mL
GUAIFENESIN100 mg/15mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9D2RTI9KYH, 495W7451VQ
Rxcui1298228

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
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
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
53145-402-062023-07-28C16284748780-1d6a99b39-382f-a426-e053-dadaa90af4c2Bisolvine
53145-402-062022-02-18C16284748780-1d6a99b39-382f-a426-e053-dadaa90af4c2Bisolvine
53145-402-062022-01-28C16284748780-1d6a99b39-382f-a426-e053-dadaa90af4c2Bisolvine

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53145-402-06BisolvineAloe-Miel180 mL in 1 BOTTLELIQUID1805
53145-402-06BisolvineAloe-Miel1 in 1 CARTONLIQUID15

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1298228dextromethorphan HBr 10 MG / guaiFENesin 100 MG in 15 mL Oral SolutionPSN34801c79-ce88-492f-808e-b639e86016075
1298228dextromethorphan hydrobromide 0.667 MG/ML / guaifenesin 6.67 MG/ML Oral SolutionSCD34801c79-ce88-492f-808e-b639e86016075
1298228dextromethorphan hydrobromide 10 MG / guaifenesin 100 MG per 15 ML Oral SolutionSY34801c79-ce88-492f-808e-b639e86016075
1298228dextromethorphan hydrobromide 20 MG / guaifenesin 200 MG per 30 ML Oral SolutionSY34801c79-ce88-492f-808e-b639e86016075

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53145-402-06531450402061 BOTTLE in 1 CARTON (53145-402-06) / 180 mL in 1 BOTTLE1 bottle2019-01-010000-00-00NoNoCurrent