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 149 of 151 · 3,010 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hydrocortisone AcetateHYDROCORTISONE ACETATEBentlin Products LLC4346351c-8e11-46ae-b428-98d17f55beb92023-10-30WarningsExact identifier
application number: M017
Biofreeze Roll-OnMENTHOLA-S Medication Solutions814b37ea-5441-4cec-8794-71ca01d849ae2023-10-30WarningsExact identifier
application number: M017
Dr. Sheffield Hydrocortisone Anti itchHYDROCORTISONESheffield Pharmaceuticals LLC71c9f2f4-2188-45eb-b55e-3856ac78070b2023-10-30WarningsExact identifier
application number: M017
Family WellnessBENZOCAINE, RESORCINOLZhejiang Jingwei Pharmaceutic Al Co., Ltd.df540eb8-6773-4647-9cc2-c3fd14d7355e2023-10-27WarningsExact identifier
application number: M017
Family WellnessHYDROCORTISONE 1%FRONT PHARMACEUTICAL PLCea26265d-f24e-458e-8bf0-287b2d49f4f42023-10-27WarningsExact identifier
application number: M017
Joint Formula 88 MAX PLUSCAMPHORSarati International, Inc.f5d78335-b78d-4909-a88b-9daa3c18ba152023-10-27WarningsExact identifier
application number: M017
OsmoFlexMENTHOLSarati International, Inc.479147c0-4cf4-4d7a-8b8e-1a0de49ed73e2023-10-27WarningsExact identifier
application number: M017
Thera plus Anti-itch with aloe HydrocortisoneHYDROCORTISONEFourstar Group USA, Inc.c69d0670-a65b-1680-e053-2995a90a2ee52023-10-26WarningsExact identifier
application number: M017
Family WellnessDIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATEFRONT PHARMACEUTICAL PLCfde2069b-344e-46da-bb95-c5113e0f35d62023-10-26WarningsExact identifier
application number: M017
MAXIMUM STRENGTH HEMORRHOIDAL RELIEFLIDOCAINECVS PHARMACY, INCb61424bf-3b23-420b-a7bc-256ddb96aa222023-10-25WarningsExact identifier
application number: M017
AssuredHYDROCORTISONEZhejiang Jingwei Pharmaceutic Al Co., Ltd.bc97f364-9443-47b8-9c2d-b5dcc00cc9b72023-10-25WarningsExact identifier
application number: M017
Stopain ClinicalMENTHOL, UNSPECIFIED FORMTroy Manufacturing, Inc.b41091b4-0dc0-4a88-8ff6-11979b3d307a2023-10-25WarningsExact identifier
application number: M017
Thera PlusHYDROCORTISONEZhejiang Jingwei Pharmaceutical Co., Ltd.bcc99e5a-2403-46da-9c9d-8411fa4104e02023-10-25WarningsExact identifier
application number: M017
AssuredLIDOCAINE HYDROCHLORIDEZhejiang Jingwei Pharmaceutical Co., Ltd.ab25c47d-bbe6-4e2b-9e39-dd9f4da3ee8c2023-10-25WarningsExact identifier
application number: M017
Red hotCAPSAICINThe Hygenic Company, LLCd100092c-e10b-2063-e053-2995a90aedb22023-10-25WarningsExact identifier
application number: M017
Stopain ClinicalMENTHOLTroy Manufacturing, Inc.c8d4ae28-efc4-6a00-e053-2a95a90a40bf2023-10-25WarningsExact identifier
application number: M017
Cryo10 Topical AnalgesicMENTHOLElement 26 LLCff1d2140-9302-918c-e053-6394a90acb9a2023-10-25WarningsExact identifier
application number: M017
Stopain ClinicalMENTHOLTroy Manufacturing, Inc.3336cc35-e773-4705-84b5-61040604beef2023-10-25WarningsExact identifier
application number: M017
CARMEX Multi-Symptom 3 in 1 COLD Sore treatment External Analgesic Skin ProtectantBENZOCAINE, WHITE PETROLATUMCarma Laboratories, Inc.bbf0abcd-b7d6-b5e4-e053-2995a90a52402023-10-25WarningsExact identifier
application number: M017
Carmex Classic Lip Balm MedicatedCAMPHOR (SYNTHETIC), WHITE PETROLATUMCarma Laboratories, Inc.bbee66b9-39ff-4e7e-e053-2995a90a43be2023-10-25WarningsExact 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