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 135 of 151 · 3,020 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CapsaicinCAPSAICINRugby Laboratoriesc5915c84-84a2-46f6-9f97-0d9873e9944a2024-02-12WarningsExact identifier
application number: M017
Leader Ice Blue AnalgesicMENTHOL, UNSPECIFIED FORMCardinal Health, 110 dba LEADER952e56ea-5cbc-4078-bd01-5d3b6864a5ce2024-02-09WarningsExact identifier
application number: M017
Leader Ultra Strength Muscle Rub Topical AnalgesicCAMPHOR (SYNTHETIC), MENTHOL, UNSPECIFIED FORM, AND METHYL SALICYLATECardinal Health, 110 dba LEADER9d99a900-60e0-454c-98e0-2c63eb910cf12024-02-09WarningsExact identifier
application number: M017
Pain RelievingCAMPHOR (NATURAL)J.R. Watkins, LLC.28821ffa-a138-47b5-8857-beadf7a20d432024-02-08WarningsExact identifier
application number: M017
Menthol Camphor Cough Suppressant Topical Analgesic RubCAMPHOR (NATURAL) AND MENTHOL, UNSPECIFIED FORMJ.R. Watkins, LLC.fd0ea70a-ef12-48b1-8d9d-cc5f6417f8542024-02-08WarningsExact identifier
application number: M017
Pain Relieving CoolingMENTHOL, UNSPECIFIED FORMJ.R. Watkins, LLC.3574d48a-b546-4ea7-b470-071bb328de642024-02-08WarningsExact identifier
application number: M017
Advil Targeted ReliefCAMPHOR, CAPSAICIN, MENTHOL, METHYL SALICYLATEHaleon US Holdings LLC16e6be21-7b43-443a-89ec-3bdf0ec0dfc12024-02-08WarningsExact identifier
application number: M017
POINT RELIEF COLD SPOT Pain RelievingMENTHOLFABRICATION ENTERPRISES96f1d592-6cec-412e-a5fd-cf3c4f68644f2024-02-07WarningsExact identifier
application number: M017
Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDESafetec of America, Inc.1c5eb3b3-79b3-472a-ae36-ec6a7dc729252024-02-07WarningsExact identifier
application number: M017
Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDESafetec of America, Inc.8eb3e7e2-26e5-430e-89aa-40a0367c637e2024-02-07WarningsExact identifier
application number: M017
Nova Natura Topical AnalgesicCAMPHOR, CAPSICUM OLEORESIN, METHYL SALICYLATESEYITLER KIMYA SANAYI ANONIM SIRKETIabf00f73-f0b1-439e-85aa-bbce8a1ec9202024-02-06WarningsExact identifier
application number: M017
Leader Burn ReliefLIDOCAINECardinal Healthf4e8e3b7-fd84-bdbc-e053-2a95a90aeab22024-02-06WarningsExact identifier
application number: M017
Pain Relieving Petro CarboPHENOLJ.R. Watkins, LLC.050cf17d-3be7-45b9-8524-ad82af309a0e2024-02-06WarningsExact identifier
application number: M017
White CreamCAMPHOR (NATURAL) AND TURPENTINE OILJ.R. Watkins, LLC.e4de0734-59d5-478c-86ea-66fc2ba003e72024-02-05WarningsExact identifier
application number: M017
Pain Relieving Roll-OnMENTHOL, UNSPECIFIED FORMSafetec of America, Inc.80118260-9c88-402d-9a90-ecfe62b4b54f2024-02-05WarningsExact identifier
application number: M017
Pain RelievingMENTHOL, UNSPECIFIED FORMSafetec of America, Inc.df512ce6-ce1b-434d-9571-fb2e1d76e1d02024-02-05WarningsExact identifier
application number: M017
Pain RelievingMENTHOLSafetec of America, Inc.52ebf64d-095f-467e-bf51-dd8d33b58c7d2024-02-05WarningsExact identifier
application number: M017
Itch ReliefDIPHENHYDRAMINE HYDROCHLORIDESafetec of America, Inc.4f4c801b-d894-4fa3-b024-6ca41a5f2a952024-02-04WarningsExact identifier
application number: M017
AnalgesicMENTHOLSafetec of America, Inc.79e3b0e7-4ba5-4b9d-a980-5b6f18dba8022024-02-04WarningsExact identifier
application number: M017
HAV EZ Penetrating Pain ReliefMENTHOLPALM ORTHOPEDICS & INTERVENTIONAL PAIN LLC70006efc-9cc8-4490-b28c-fcb23b1737c42024-02-01WarningsExact 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