FDA.reportPublic FDA data

AVCOO Pain Relief Roll-on

Product NDC
84992-001
11-digit product format
849920001
Labeler code
84992
Product ID
84992-001_2af0c265-3f2c-b0fb-e063-6294a90ab5a1
Type
HUMAN OTC DRUG
Nonproprietary name
MENTHOL
Dosage form
CREAM
Route
TOPICAL
Labeler
ADP Health Limited
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-01-04
Substance
MENTHOL
Active strength
4 g/100mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
AVCOO Pain Relief Roll-on
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL4 g/100mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiL7T10EIP3A
Rxcui1148430

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84992-001-01AVCOO Pain Relief Roll-on74 mL in 1 BOTTLECREAM742
84992-001-02AVCOO Pain Relief Roll-on1 in 1 CASECREAM12
84992-001-02AVCOO Pain Relief Roll-on74 mL in 1 BOTTLECREAM742
84992-001-03AVCOO Pain Relief Roll-on74 mL in 1 BOTTLECREAM742
84992-001-03AVCOO Pain Relief Roll-on2 in 1 CASECREAM22
84992-001-04AVCOO Pain Relief Roll-on74 mL in 1 BOTTLECREAM742
84992-001-04AVCOO Pain Relief Roll-on3 in 1 CASECREAM32

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84992-001AVCOO PAIN RELIEF ROLL-ON (MENTHOL) CREAM [ADP HEALTH LIMITED]2Current NDC, 7 package rows20250106_e0bb77b2-45ee-45fa-9659-9c7d99bb20dc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1148430menthol 4 % Topical CreamPSNe0bb77b2-45ee-45fa-9659-9c7d99bb20dc2
1148430menthol 40 MG/ML Topical CreamSCDe0bb77b2-45ee-45fa-9659-9c7d99bb20dc2
1148430menthol 4 % Topical CreamSYe0bb77b2-45ee-45fa-9659-9c7d99bb20dc2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84992-001-018499200010174 mL in 1 BOTTLE (84992-001-01) 74 ml2025-01-04NoNoHistorical
84992-001-02849920001021 BOTTLE in 1 CASE (84992-001-02) / 74 mL in 1 BOTTLE1 bottle2025-01-05NoNoHistorical
84992-001-03849920001032 BOTTLE in 1 CASE (84992-001-03) / 74 mL in 1 BOTTLE2 bottle2025-01-05NoNoHistorical
84992-001-04849920001043 BOTTLE in 1 CASE (84992-001-04) / 74 mL in 1 BOTTLE3 bottle2025-01-05NoNoHistorical