FDA.reportPublic FDA data

Aulief

Product NDC
76305-302
11-digit product format
763050302
Labeler code
76305
Product ID
76305-302_42c89af1-c7d8-0ee3-e063-6394a90a3aef
Type
HUMAN OTC DRUG
Nonproprietary name
Menthol and Camohor
Dosage form
CREAM
Route
TOPICAL
Labeler
China-Gel, LLC
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-05-14
Substance
CAMPHOR (NATURAL); MENTHOL
Active strength
30; 50 mg/g; mg/g
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
Aulief
Brand name suffix
Topical Pain Reliever
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CAMPHOR (NATURAL)30 mg/g
MENTHOL50 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
N20HL7Q941Internal UNII lookup
L7T10EIP3AInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1312283Internal RxNorm lookup
2168358Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
8647dcc3-1dbc-1093-e053-2991aa0a1ab9Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76305-302-01AuliefTopical Pain Reliever90.7 g in 1 TUBECREAM90.74
76305-302-02AuliefTopical Pain Reliever198.5 g in 1 TUBECREAM198.54
76305-302-03AuliefTopical Pain Reliever453.6 g in 1 BOTTLECREAM453.64

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76305-302AULIEF TOPICAL PAIN RELIEVER (MENTHOL AND CAMOHOR) CREAM [CHINA-GEL, LLC]3Current NDC, Legacy NDC, 3 package rows20231220_8647dcc3-1dbc-1093-e053-2991aa0a1ab9.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 124 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Eagle MedicatedMENTHOL METHYL SALICYLATEEagle Indo Pharma, PTda338796-de9c-be51-e053-2a95a90a25092024-10-07WarningsExact identifier
application number: M017
Eagle MedicatedMENTHOL METHYL SALICYLATEEagle Indo Pharmae2c5f821-cdd5-190d-e053-2a95a90a91592024-10-07WarningsExact identifier
application number: M017
NanoXtreme Pain RelievingMENTHOL, METHYL SALICYLATEMG Science Technologies LLCc1490c30-a9db-4120-adaf-9e8000169e462024-10-07WarningsExact identifier
application number: M017
CAREALL Hydrocortisone Maximum StrengthHYDROCORTISONENew World Imports, Incea656cf8-cad5-4fa5-82e7-daec77a0bb042024-10-07WarningsExact identifier
application number: M017
Eagle Medicated Oil RefreshingMENTHOL, METHYL SALICYLATEEagle Indo Pharma, PTe2729023-d689-7ae2-e053-2a95a90a78dc2024-10-06WarningsExact identifier
application number: M017
Flanax Back Pain ReliefLIDOCAINEBelmora LLC46d33346-e582-4af1-b81a-feca7033dceb2024-10-04WarningsExact identifier
application number: M017
Muscle BalmMENTHOL, UNSPECIFIED FORM, CAMPHOR (SYNTHETIC)Natural Essentials, Inc.16918ba3-2e07-4232-9ed3-4c7751796cd22024-10-04WarningsExact identifier
application number: M017
Fast Freeze Pain Relieving ContinuousMENTHOL, UNSPECIFIED FORMNatural Essentials, Inc.998a4824-9ed9-4fe0-b45b-72e52861fcd32024-10-04WarningsExact identifier
application number: M017
Fast Freeze Lidocaine Roll-OnLIDOCAINE HYDROCHLORIDE, BENZYL ALCOHOLNatural Essentials, Inc.74b06366-5eb4-4eba-aa2b-2b672828294d2024-10-04WarningsExact identifier
application number: M017
Fast Freeze LidocaineLIDOCAINENatural Essentials, Inc.029bd3fb-1b5b-48e0-b9af-d91d548b5b0f2024-10-04WarningsExact identifier
application number: M017
Fast FreezeMENTHOLNatural Essentials Inc.a96e3e41-871c-4cf3-93b6-af2a6246ded82024-10-04WarningsExact identifier
application number: M017
CVS Pain ReliefMENTHOL 4%CVS20234356-5e80-b79e-e063-6294a90a2ee32024-10-04WarningsExact identifier
application number: M017
FLANAX BACK PAIN RELIEFLIDOCAINEBelmora Llcaf4bf57c-f250-4506-83eb-e0f253e960622024-10-04WarningsExact identifier
application number: M017
topcare hydrocortisoneHYDROCORTISONETopco Associates LLC11a30ec9-ebc2-4a00-8a8d-431d0d973b372024-10-03WarningsExact identifier
application number: M017
pain relief patchLIDOCAINE 4%Bionpharma Inc.19c69983-4e78-8ec5-e063-6394a90a84be2024-10-03WarningsExact identifier
application number: M017
Good Sense Anti ItchHYDROCORTISONEL. Perrigo Companyecd6d841-40b9-42c9-825d-d172cd04824d2024-10-03WarningsExact identifier
application number: M017
Gold Bond Medicated Original Strength BodyMENTHOLNavajo Manufacturing Company Inc.f71d598c-92c3-d6fd-e053-6394a90a97d72024-10-03WarningsExact identifier
application number: M017
Signature Care HydrocortisoneHYDROCORTISONESafeway9e663535-4acc-4b37-acae-8c17517c5a3d2024-10-03WarningsExact identifier
application number: M017
Topcare HydrocortisoneHYDROCORTISONETopco Associates LLC849c60fc-e455-4c50-8adf-ac59c0ee785b2024-10-03WarningsExact identifier
application number: M017
rexall anti itch maximum strength reliefHYDROCORTISONEDolgencorp, LLC894cf9ab-693a-4210-96df-605947f51b632024-10-03WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2168358aulief 3 % / 5 % Topical CreamPSN8647dcc3-1dbc-1093-e053-2991aa0a1ab94
1312283camphor 3 % / menthol 5 % Topical CreamPSN8647dcc3-1dbc-1093-e053-2991aa0a1ab94
2168358camphor 30 MG/ML / menthol 50 MG/ML Topical Cream [Aulief]SBD8647dcc3-1dbc-1093-e053-2991aa0a1ab94
1312283camphor 30 MG/ML / menthol 50 MG/ML Topical CreamSCD8647dcc3-1dbc-1093-e053-2991aa0a1ab94
2168358Aulief (camphor 3 % / menthol 5 % ) Topical CreamSY8647dcc3-1dbc-1093-e053-2991aa0a1ab94
1312283camphor 3 % / menthol 5 % Topical CreamSY8647dcc3-1dbc-1093-e053-2991aa0a1ab94

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
76305-302-017630503020190.7 g in 1 TUBE (76305-302-01) 90.7 g2019-05-140000-00-00NoNoCurrent
76305-302-0276305030202198.5 g in 1 TUBE (76305-302-02) 198.5 g2019-05-140000-00-00NoNoCurrent
76305-302-0376305030203453.6 g in 1 BOTTLE (76305-302-03) 453.6 g2019-05-140000-00-00NoNoCurrent