FDA.reportPublic FDA data

Vicks VapoCool

Product NDC
69423-796
11-digit product format
694230796
Labeler code
69423
Product ID
69423-796_5d18e3cc-6aca-6f8f-e063-6294a90a93ee
Type
HUMAN OTC DRUG
Nonproprietary name
Menthol
Dosage form
LOZENGE
Route
ORAL
Labeler
The Procter & Gamble Manufacturing Company
Application
M022
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-07-13
Substance
MENTHOL
Active strength
20 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
Vicks VapoCool
Brand name suffix
SEVERE
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL20 mg/1

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69423-796-05Vicks VapoCoolSEVERE1 in 1 POUCHLOZENGE19
69423-796-05Vicks VapoCoolSEVERE225 in 1 BAGLOZENGE2259
69423-796-18Vicks VapoCoolSEVERE18 in 1 BAGLOZENGE189
69423-796-18Vicks VapoCoolSEVERE1 in 1 POUCHLOZENGE19
69423-796-45Vicks VapoCoolSEVERE1 in 1 POUCHLOZENGE19
69423-796-45Vicks VapoCoolSEVERE45 in 1 BAGLOZENGE459
69423-796-70Vicks VapoCoolSEVERE70 in 1 BAGLOZENGE709
69423-796-70Vicks VapoCoolSEVERE1 in 1 POUCHLOZENGE19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69423-796VICKS VAPOCOOL SEVERE (MENTHOL) LOZENGE [THE PROCTER & GAMBLE MANUFACTURING COMPANY]8Current NDC, 8 package rows20250504_c77f8878-5eef-b006-e053-2a95a90a1866.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 19 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Povi-OnePOVIDONE-IODINE 10% TOPICALElevate Oral Caref5252b4f-5e14-509e-e053-2995a90a6db82025-09-18WarningsExact identifier
application number: M022
Patterson Dental Topical AnestheticBENZOCAINEPatterson Dental3f199947-bf25-914b-e063-6394a90a8a6f2025-09-18WarningsExact identifier
application number: M022
Patterson Dental Topical AnestheticBENZOCAINEPatterson Dental3f199947-bf28-914b-e063-6394a90a8a6f2025-09-18WarningsExact identifier
application number: M022
Patterson Dental Topical AnestheticBENZOCAINEPatterson Dental3f19a1a7-c234-8d26-e063-6394a90ad7e92025-09-18WarningsExact identifier
application number: M022
McKesson Orasol GelBENZOCAINE 20%McKesson Medical-Surgicalcc8724f4-c482-5e7d-e053-2a95a90a608f2025-09-09WarningsExact identifier
application number: M022
MGC Health Drops Sugar Free Lemon MintMENTHOLMedical Group Care LLC3d70bca7-e830-e693-e063-6294a90a73f92025-08-28WarningsExact identifier
application number: M022
Exchange Select Drops Sugar Free Lemon MintMENTHOLArmy & Air Force Exchange Service3d70450f-04ea-1885-e063-6294a90a05bd2025-08-28WarningsExact identifier
application number: M022
Ki No SinCALCIUM CARBONATENPG Bio Pharmaceuticals Co.,Ltd.21fa2bad-5b8b-8aac-e063-6394a90a9f492025-08-27WarningsExact identifier
application number: M022
R CosCALCIUM CARBONATENPG Bio Pharmaceuticals Co.,Ltd.21fa767a-1344-5ed9-e063-6394a90a5fe62025-08-27WarningsExact identifier
application number: M022
Na Mi CalCALCIUM CARBONATENPG Bio Pharmaceuticals Co.,Ltd.20cfbcd1-eb13-933c-e063-6294a90a7e592025-08-27WarningsExact identifier
application number: M022
Ki No SinCALCIUM CARBONATENPG Bio Pharmaceuticals Co.,Ltd.20cf8f80-c638-4d94-e063-6294a90a54002025-08-27WarningsExact identifier
application number: M022
Charm Tex FLUORIDESODIUM MONOFLUOROPHOSPHATEYangzhou Hongshengding Chemical Co.,Ltd.63a69664-8611-4d69-b871-8d1d5b553e5c2025-08-18WarningsExact identifier
application number: M022
QUALITY CHOICE SALINESODIUM CHLORIDEQUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)f51491d8-12ad-4b1b-a171-c621bfdcc3412025-08-12WarningsExact identifier
application number: M022
MGC Health Drops Sugar Free Lemon MintMENTHOLXiamen Kang Zhongyuan Biotechnology Co., Ltd.b9227966-847c-40c3-87f2-8bea3954ec842025-08-12WarningsExact identifier
application number: M022
Exchange Select Drops Sugar Free Lemon MintMENTHOLXiamen Kang Zhongyuan Biotechnology Co., Ltd.5f4b1960-43ac-4c74-9410-210c48bd8a1b2025-08-12WarningsExact identifier
application number: M022
HurriCaine Topical AnestheticBENZOCAINEBeutlich Pharmaceuticals, LLC113cdb83-0fdd-40f2-8ee6-b771dca997132025-08-12WarningsExact identifier
application number: M022
CVS Pharmacy Maximum StrengthBENZOCAINECVS Pharmacy13bf31c1-78e3-459f-9249-b0b6e2c17a132025-08-12WarningsExact identifier
application number: M022
Rexall Maximum StrengthBENZOCAINERexall8f6e2780-cfb7-4bef-9b7d-13cb80d8923e2025-08-12WarningsExact identifier
application number: M022
Walgreens Maximum StrengthBENZOCAINEWalgreens8f24309d-d393-455a-a9a5-a55344adf36b2025-08-12WarningsExact identifier
application number: M022
Oral Anesthetic LiquidBENZOCAINEMeijer, Inc.0321c480-e150-421d-e063-6294a90ad6872025-08-12WarningsExact identifier
application number: M022

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1995300menthol 20 MG Oral LozengePSNc77f8878-5eef-b006-e053-2a95a90a18669
1995300menthol 20 MG Oral LozengeSCDc77f8878-5eef-b006-e053-2a95a90a18669

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
69423-796-0569423079605225 POUCH in 1 BAG (69423-796-05) / 1 LOZENGE in 1 POUCH225 pouch2021-07-13NoNoCurrent
69423-796-186942307961818 POUCH in 1 BAG (69423-796-18) / 1 LOZENGE in 1 POUCH18 pouch2021-07-13NoNoCurrent
69423-796-456942307964545 POUCH in 1 BAG (69423-796-45) / 1 LOZENGE in 1 POUCH45 pouch2021-07-13NoNoCurrent
69423-796-706942307967070 POUCH in 1 BAG (69423-796-70) / 1 LOZENGE in 1 POUCH70 pouch2025-07-01NoNoCurrent