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
2027-12-31
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
Bisolvine
Brand name suffix
Aloe-Miel
Listing expiration
2027-12-31

Active Ingredients#

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

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
1298228Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
34801c79-ce88-492f-808e-b639e8601607Available 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
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

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 139 of 177 · 3,534 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SUDAFED PE Head Congestion Plus Flu SevereACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEKenvue Brands LLC1e528f78-0ced-4a06-935a-84056c9217272024-11-08WarningsExact identifier
application number: M012
TYLENOL Cold Plus Flu Severe and TYLENOL COLD MAX CoPackACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEKenvue Brands LLC657a1e59-104c-4152-b2c9-00a8b82dc78e2024-11-08WarningsExact identifier
application number: M012
Tylenol Cold plus Flu Severe and Tylenol Cold MaxACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEKenvue Brands LLC47c61858-72ce-409b-a3af-a63620cf7d132024-11-08WarningsExact identifier
application number: M012
Childrens Benadryl Allergy Plus CongestionDIPHENHYDRAMINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDEKenvue Brands LLCb8b75904-3806-4258-89c1-d6ff486ed41c2024-11-08WarningsExact identifier
application number: M012
Tylenol Cold Plus Flu Severe Day and Tylenol Cold Plus Flu Plus Cough Night 3-PackACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, AND GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEKenvue Brands LLC464de5de-0e7a-41d6-875f-dd0e5fe7893c2024-11-08WarningsExact identifier
application number: M012
McKesson Phenylephrine HClPHENYLEPHRINE HCLMcKesson Medical-Surgicale09060f7-ca0b-5f7c-e053-2995a90ab3442024-11-08WarningsExact identifier
application number: M012
daytime severeACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDECVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDe0e216ef-300c-4f57-87e6-62a5327e09b42024-11-08WarningsExact identifier
application number: M012
basic care daytime severe cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEAmazon.com Services LLC969c0718-ba6e-4edb-9f55-43bc9500450f2024-11-08WarningsExact identifier
application number: M012
daytime severe cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEWalgreen Company62a70d9a-4e78-497c-8f75-012ab94e92f62024-11-08WarningsExact identifier
application number: M012
adult tussin dmDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINPublix Super Markets Inc25b2ad8a-5835-4496-815f-73a7fb40dcfd2024-11-08WarningsExact identifier
application number: M012
severe cold and flu reliefACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDERite Aid Corporation296f20c0-8b5f-4a08-9329-f93c92e638672024-11-08WarningsExact identifier
application number: M012
topcare tussin dmDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINTopco Associates LLCd3cae69e-41a5-4099-a3f4-ce25fd94df732024-11-08WarningsExact identifier
application number: M012
foster and thrive daytime severe cold and flu reliefACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEStrategic Sourcing Services LLC9d147d1e-8ea5-4e0f-8ae8-1da16f1194962024-11-08WarningsExact identifier
application number: M012
equate adult cough and chest congestion dmDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINWALMART INC.e770bdb2-3662-4538-8199-fe4a4059c7202024-11-08WarningsExact identifier
application number: M012
DG Health Cold and Flu SevereACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEDolgencorp Inc23dcb627-c867-435f-9d1a-a9f49e58b58f2024-11-08WarningsExact identifier
application number: M012
good neighbor pharmacy adult tussin DMDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINAmerisource Bergenced71993-f535-4e28-bc1d-3fcb7d86e9b72024-11-08WarningsExact identifier
application number: M012
adult tussin dmDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINCVS Pharmacy2f1dc8f8-79c5-4724-99aa-a55330ed9d5f2024-11-08WarningsExact identifier
application number: M012
good sense day time cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEL. Perrigo Company4ac6b64a-8214-4b03-8aa5-0d3199cf0b722024-11-08WarningsExact identifier
application number: M012
tussinDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINH E B1dd9afb6-9b58-4274-a557-900a0cb235242024-11-08WarningsExact identifier
application number: M012
DG health sinus severeOXYMETAZOLINE HYDROCHLORIDEDolgencorp, LLC7abaa912-be8b-463c-8818-104e79b335392024-11-07WarningsExact identifier
application number: M012

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