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

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
AVCOO Pain Relief Roll-on
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL4 g/100mL

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
1148430Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
e0bb77b2-45ee-45fa-9659-9c7d99bb20dcAvailable on FDA.report

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

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 129 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ReliefMENTHOLLa Mend, Inc.1f92de3a-7180-5884-e063-6294a90aebf52024-08-01WarningsExact identifier
application number: M017
Meijer Medicated Foot PowderMENTHOLMeijer Distribution07ec6c20-73c4-e5e4-e063-6294a90a7e552024-07-29WarningsExact identifier
application number: M017
Ralli Rapid Pain ReliefMENTHOLTroy Manufacturing, Inc.e05ec3b7-e9ab-4eaa-8518-86304336697c2024-07-29WarningsExact identifier
application number: M017
Walgreens Roll-OnCAPSAISIN 0.1%Walgreens Co1e65bf31-15c7-5e6a-e063-6394a90ac9562024-07-29WarningsExact identifier
application number: M017
CamphotrexCAMPHOR, MENTHOLPureTek Corporation3b6c6eef-e92d-497d-afe8-82356637c2b82024-07-26WarningsExact identifier
application number: M017
CamphotrolCAMPHOR, MENTHOLPureTek Corporationccac9f37-a374-4765-e053-2a95a90ad2f72024-07-26WarningsExact identifier
application number: M017
Real Time Pain Relief FootMENTHOLReal Time Products Inc.29c8e06d-9b29-44f9-ac21-9160d06475cb2024-07-24WarningsExact identifier
application number: M017
Capsaicin 0.075 PercentCAPSAICINAlexso, Inc33d2a9cd-0ca1-4e19-8b7a-f899f1205cbd2024-07-22WarningsExact identifier
application number: M017
TIDL Pain Relief CRYO Therapy Limited EditionPAIN RELIEF CRYO THERAPY LIMITED EDITIONShenzhen Sam Technology Co., Ltd.1d966b67-fd9c-eab6-e063-6294a90aa75e2024-07-19WarningsExact identifier
application number: M017
Fruit of the Earth Aloe Vera Cool BlueLIDOCAINE HYDROCHLORIDEFruit of the Earth, Inc.1d65bc34-2bc2-4f52-a9b3-1cb08324eb792024-07-19WarningsExact identifier
application number: M017
Ultra BalmMENTHOL AND METHYL SALICYLATELing Nam Medicine Factory (H.K.) Ltd.de997baf-aa04-474e-b912-3fc67e720d0b2024-07-19WarningsExact identifier
application number: M017
Ling Nam Hak Kwai OilTURPENTINE OILLing Nam Medicine Factory (H.K.) Ltd.3f16cce3-366f-41f3-8829-6de4082a8c192024-07-19WarningsExact identifier
application number: M017
Koong Yick Hak Kwai OilTURPENTINE OILLing Nam Medicine Factory (H.K.) Ltd.bc33e185-3b42-98b5-e053-2995a90a63082024-07-18WarningsExact identifier
application number: M017
Koong Yick Hung FaMETHYL SALICYLATELing Nam Medicine Factory (H.K.) Ltd.9c8a121d-6da2-4435-a2d7-a0b71d10740d2024-07-18WarningsExact identifier
application number: M017
Ling Nam Hung FarMETHYL SALICYLATELing Nam Medicine Factory (H.K.) Ltd.b6916b6e-b7eb-1eb7-e053-2995a90ae6fb2024-07-18WarningsExact identifier
application number: M017
itch reliefDIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATEBionpharma Inc.178ed513-4f22-8f11-e063-6294a90a109b2024-07-16WarningsExact identifier
application number: M017
POWERECT Benzocaine Male Delay GelBENZOCAINESKINS SEXUAL HEALTH LIMITED2fafe1f2-a31e-4b2a-bc51-81e16b319c3a2024-07-16WarningsExact identifier
application number: M017
SKINS DELAY Climax Control Benzocaine GelBENZOCAINESKINS SEXUAL HEALTH LIMITED53730576-2609-4f28-8bfa-a1ceea698b832024-07-16WarningsExact identifier
application number: M017
TIDL PAIN RELIEF CRYO THERAPY Unscented formula Spray.PAIN RELIEF CRYO THERAPY UNSCENTED FORMULA SPRAYShenzhen Sam Technology Co., Ltd.1d1a0346-3b00-4803-e063-6294a90aec6d2024-07-13WarningsExact identifier
application number: M017
Tidl Pain Relief Evening Therapy Spray.PAIN RELIEF EVENING THERAPY SPRAYShenzhen Sam Technology Co., Ltd.1d1a2f4a-7b25-e595-e063-6394a90a00d52024-07-13WarningsExact identifier
application number: M017

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 ml2025-01-04NoNoCurrent
84992-001-02849920001021 BOTTLE in 1 CASE (84992-001-02) / 74 mL in 1 BOTTLE1 bottle2025-01-05NoNoCurrent
84992-001-03849920001032 BOTTLE in 1 CASE (84992-001-03) / 74 mL in 1 BOTTLE2 bottle2025-01-05NoNoCurrent
84992-001-04849920001043 BOTTLE in 1 CASE (84992-001-04) / 74 mL in 1 BOTTLE3 bottle2025-01-05NoNoCurrent