FDA.reportPublic FDA data

Vapor Shower

Product NDC
83698-005
11-digit product format
836980005
Labeler code
83698
Product ID
83698-005_2cf2f363-2b77-f131-e063-6394a90a1d7a
Type
HUMAN OTC DRUG
Nonproprietary name
Menthol
Dosage form
TABLET
Route
TOPICAL
Labeler
Xiamen Kang Zhongyuan Biotechnology Co., Ltd.
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-01-01
Substance
MENTHOL
Active strength
.45 mg/1
NDC exclude flag
No
Listing certified through
2026-12-31
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
Vapor Shower
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL.45 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 SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
2cf2f35b-5d59-e3ff-e063-6294a90a9b45Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83698-005-10Vapor Shower10 in 1 PACKAGETABLET102

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83698-005VAPOR SHOWER (MENTHOL) TABLET [XIAMEN KANG ZHONGYUAN BIOTECHNOLOGY CO., LTD.]2Current NDC, 1 package rows20250201_2cf2f35b-5d59-e3ff-e063-6294a90a9b45.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 165 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dimetapp Cough and AllergyDIPHENHYDRAMINE HYDROCHLORIDEFoundation Consumer Healthcare15b0f5ff-202a-d19f-e063-6394a90af2b82024-04-15WarningsExact identifier
application number: M012
Nighttime Severe Cold and CoughACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCLP & L Development, LLC8d27b94d-23a1-4e6c-a064-79e2580f7e2e2024-04-15WarningsExact identifier
application number: M012
Severe Cold and Cough Relief DaytimeACETAMINOHPEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLP & L Development, LLC2af496a1-6fdd-4acf-9944-8b7cdf3022752024-04-15WarningsExact identifier
application number: M012
Childrens Dye Free AllergyDIPHENHYDRAMINE HYDROCHLORIDEP & L Development, LLC1c4d09ed-4e0f-430d-b17f-6a23f996a55d2024-04-15WarningsExact identifier
application number: M012
Theraflu ExpressMax Daytime Nighttime Value PackACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL AND ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCLHaleon US Holdings LLC9736ad4c-8c2e-421f-b023-f91b72d2828b2024-04-10WarningsExact identifier
application number: M012
Theraflu Multi-Symptom Severe Cold and Theraflu Nighttime Severe Cold and CoughACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, DIPHENHYDRAMINE HCLHaleon US Holdings LLCb06b64c5-dbb4-4ef5-af18-3d7d4979c02f2024-04-10WarningsExact identifier
application number: M012
Daytime Nighttime Cold and FluACETAMINOPHEN DEXTROMETHORPHAN HBR PHENYLEPHRINE HCI DOXYLAMINESUCINATEHarris Teeter, LLCec603195-eb36-4b5c-bc9b-c2074205b2b22024-04-09WarningsExact identifier
application number: M012
Daytime Cold and Flu Non drowsyACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEHarris Teeter, LLC9b0648ac-0ce3-4eaa-8977-26ae864f034d2024-04-09WarningsExact identifier
application number: M012
Theraflu Severe Cold Relief Combo PackACETAMINOPHEN, DEXTROMETHORPHAN HBR, DIPHENHYDRAMINE HCLHaleon US Holdings LLCf147d82e-4429-4c7b-bd2b-e21a09f21c922024-04-09WarningsExact identifier
application number: M012
FLONASE Headache and Allergy ReliefACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCLHaleon US Holdings LLC282c103c-3888-4a35-a5b1-d492ed6892c12024-04-08WarningsExact identifier
application number: M012
ROBITUSSIN COUGH PLUS CHEST CONGESTION DMDEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESINHaleon US Holdings LLC4908b326-e1da-44ca-8087-7e41a16c27b02024-04-08WarningsExact identifier
application number: M012
Robitussin Direct Sore Throat PainACETAMINOPHENHaleon US Holdings LLC1b512078-24c3-4b80-8f2c-d6824d367f252024-04-08WarningsExact identifier
application number: M012
Mucus Relief Cough ChildrensDEXTROMETHORPHAN HBR, GUAIFENSINH E B9ba5ca1b-2e3c-439e-8887-c26f144b88ef2024-04-08WarningsExact identifier
application number: M012
Cold and Flu Relief DaytimeACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEH E B12ace982-bd47-49b0-ba1b-e0a29d42f1d62024-04-08WarningsExact identifier
application number: M012
Allergy ChildrensDIPHENHYDRAMINE HYDROCHLORIDEH E Bab28cbc4-7a6f-46e9-8616-be78e8cb24fe2024-04-08WarningsExact identifier
application number: M012
Cold and Flu Relief DaytimeACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEH E Bbd19b1f2-d9d3-4dab-8181-605f769ab62f2024-04-08WarningsExact identifier
application number: M012
Daytime Severe Cold and CoughACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLH E B9f533092-060c-4379-9a77-ecfea8aa46e12024-04-08WarningsExact identifier
application number: M012
Robitussin Severe Multi-Symptom Cough Cold FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEHaleon US Holdings LLC66360295-f364-479a-8b49-c12b219182792024-04-06WarningsExact identifier
application number: M012
Robitussin Peak Cold Multi-Symptom ColdDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEHaleon US Holdings LLC8c0a2424-e8ac-d91c-b46d-a5ee29f919362024-04-06WarningsExact identifier
application number: M012
Robitussin Maximum Strength Severe Multi-Symptom 7 in 1 Relief NighttimeACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATEHaleon US Holdings LLCe7cf7c5d-5c9a-4201-9e30-1cd6160718552024-04-06WarningsExact identifier
application number: M012

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83698-005-108369800051010 TABLET in 1 PACKAGE (83698-005-10) 10 tablet2025-01-01NoNoCurrent