FDA.reportPublic FDA data

MGC Health

Product NDC
83698-113
11-digit product format
836980113
Labeler code
83698
Product ID
83698-113_4df013ee-7fe0-5af7-e063-6294a90a6731
Type
HUMAN OTC DRUG
Nonproprietary name
Cough Drops Menthol Sugar-Free
Dosage form
LOZENGE
Route
ORAL
Labeler
Xiamen Kang Zhongyuan Biotechnology Co., Ltd.
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-02-12
Substance
MENTHOL
Active strength
5.4 mg/1
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
MGC Health
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL5.4 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
L7T10EIP3AInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
485287Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
29f2fa8c-071f-50ab-e063-6394a90a4a4aAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83698-113-25MGC Health25 in 1 BAGLOZENGE253
83698-113-70MGC Health70 in 1 BAGLOZENGE703

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83698-113MGC HEALTH (COUGH DROPS MENTHOL SUGAR-FREE) LOZENGE [XIAMEN KANG ZHONGYUAN BIOTECHNOLOGY CO., LTD.]1Current NDC, 2 package rows20241225_29f2fa8c-071f-50ab-e063-6394a90a4a4a.zip

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 132 of 177 · 3,534 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Acetaminophen, Chlorpheniramine Maleate, Phenylephrine HClACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCLOPMX LLCb373a3a8-68c4-0187-e053-2995a90aad622024-12-03WarningsExact identifier
application number: M012
Mucus Relief Cold and Flu All In OneACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDETOPCAREa1b281ec-fd42-963c-e053-2a95a90a4b712024-12-03WarningsExact identifier
application number: M012
Mucus Relief Cold Flu and Sore ThroatACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDETOPCO ASSOCIATES LLCb3366ad4-5ef4-eb70-e053-2995a90acf332024-12-03WarningsExact identifier
application number: M012
Meijer Medicated Chest Rub, 3.53 oz. LavenderMENTHOL, CAMPHOR, EUCALYPTUS OILMeijer Distribution22516f25-b8aa-7511-e063-6394a90a61252024-12-03WarningsExact identifier
application number: M012
Tenalif ChildrenACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLOPMX LLC05cd9513-1a42-e990-e063-6294a90a57df2024-12-03WarningsExact identifier
application number: M012
Tenalif Multi Symptom ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLOPMX LLC05cd94e7-1808-3bb3-e063-6294a90a41402024-12-03WarningsExact identifier
application number: M012
Nasal Decongestant PE and Pain Relief Plus Mucus ReliefACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEWinco Foods, LLC31531f90-8933-46ab-b722-cb63e77386392024-12-03WarningsExact identifier
application number: M012
Mucus Relief Sinus Pressure Pain and CoughACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEWINCO FOODS, LLCf45f3ab4-5e10-3004-e053-2a95a90a0cb42024-12-03WarningsExact identifier
application number: M012
good sense allergyDIPHENHYDRAMINE HCLNuCare Pharmaceuticals, Inc.2861b801-e778-822d-e063-6394a90aa1a82024-12-03WarningsExact identifier
application number: M012
Sinus plus HeadacheACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDECHAIN DRUG MARKETING ASSOCIATION INCfe0cf681-f42c-430c-8429-f7ba4bc5a9762024-12-02WarningsExact identifier
application number: M012
Allergy MultisymptomACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE HYDROCHLORIDECHAIN DRUG MARKETING ASSOCIATION INC5a5aa2ee-51b7-4698-bb27-3fb9d01bbea52024-12-02WarningsExact identifier
application number: M012
Mucus Relief Sinus Severe Congestion ReliefACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEChain Drug Marketing Association0ea270b7-9c28-49fb-9615-c4afdbdbc8f12024-12-02WarningsExact identifier
application number: M012
Head Congestion Mucus PEACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDECHAIN DRUG MARKETING ASSOCIATION INC0955d856-cc4e-4ef2-8bc0-1a632a5b5f792024-12-02WarningsExact identifier
application number: M012
Head Congestion Flu Severe PEACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDECHAIN DRUG MARKETING ASSOCIATION INC40c9c90d-6c9e-40d0-921d-1fd34eff90bb2024-12-02WarningsExact identifier
application number: M012
Mucus Relief Sinus Pressure Pain and CoughACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDECHAIN DRUG MARKETING ASSOCIATION INC3d068d30-9a00-49d7-bbe9-d6b53c19e86d2024-12-02WarningsExact identifier
application number: M012
DiphenhydramineDIPHENHYDRAMINE HYDROCHLORIDEAAA Pharmaceutical, Inc.76724432-ff3c-404f-ba1f-5af68e3ab8c42024-12-02WarningsExact identifier
application number: M012
Sinus and HeadacheACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDEAAA Pharmaceutical, Inc.73d4fc82-8508-44f8-83ca-9f32c5cd847b2024-12-02WarningsExact identifier
application number: M012
Allergy Multi SymptomACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE HYDROCHLORIDEAAA PHARMACEUTICAL, INC.19898135-0f7b-45a5-a672-14c49fd210772024-12-02WarningsExact identifier
application number: M012
MUCUS RELIEFGUAIFENESINGeri-Care Pharmaceuticals, Corpbb72de5d-d3c0-42fc-ae52-a3ad95214af52024-12-02WarningsExact identifier
application number: M012
Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine HydrochlorideACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEAAA Pharmaceutical, Inc.a242e005-0330-4afb-83b8-13c7d56f5c6d2024-12-02WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
485287menthol 5.4 MG Oral LozengePSN29f2fa8c-071f-50ab-e063-6394a90a4a4a3
485287menthol 5.4 MG Oral LozengeSCD29f2fa8c-071f-50ab-e063-6394a90a4a4a3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83698-113-258369801132525 LOZENGE in 1 BAG (83698-113-25) 25 lozenge2023-02-12NoNoCurrent
83698-113-708369801137070 LOZENGE in 1 BAG (83698-113-70) 70 lozenge2023-02-12NoNoCurrent