FDA.reportPublic FDA data

PREMIERES PAIN

Product NDC
32472-102
11-digit product format
324720102
Labeler code
32472
Product ID
32472-102_46a6eefe-da37-067e-e063-6294a90a314c
Type
HUMAN OTC DRUG
Nonproprietary name
menthol
Dosage form
SPRAY
Route
TOPICAL
Labeler
Premiere Enterprises
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2010-12-28
Substance
MENTHOL
Active strength
.07 g/mL
NDC exclude flag
No
Listing certified through
2027-12-31
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
PREMIERES PAIN
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL.07 g/mL

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
1086713Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
128bd1e7-e961-416c-933b-fbd146e3d386Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
32472-102-01Premieres Pain29.5 mL in 1 BOTTLESPRAY29.56
32472-102-03PREMIERES PAIN88 mL in 1 BOTTLESPRAY886
32472-102-04PREMIERES PAIN118 mL in 1 BOTTLESPRAY1186

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
mentholACTIVE INGREDIENTL7T10EIP3APREMIERE PAIN ROLL ON (MENTHOL) SPRAY [PREMIERE ENTERPRISES]2
mentholACTIVE INGREDIENTL7T10EIP3AANALGESIC (MENTHOL) SPRAY [PREMIERE ENTERPRISES]2
mentholACTIVE INGREDIENTL7T10EIP3APREMIERES PAIN (MENTHOL) SPRAY [PREMIERE ENTERPRISES]2
mentholACTIVE MOIETYL7T10EIP3AANALGESIC (MENTHOL) SPRAY [PREMIERE ENTERPRISES]2
mentholACTIVE MOIETYL7T10EIP3APREMIERE PAIN ROLL ON (MENTHOL) SPRAY [PREMIERE ENTERPRISES]2
mentholACTIVE MOIETYL7T10EIP3APREMIERES PAIN (MENTHOL) SPRAY [PREMIERE ENTERPRISES]2
coconut oilINACTIVE INGREDIENTQ9L0O73W7LPREMIERE PAIN ROLL ON (MENTHOL) SPRAY [PREMIERE ENTERPRISES]2
coconut oilINACTIVE INGREDIENTQ9L0O73W7LPREMIERES PAIN (MENTHOL) SPRAY [PREMIERE ENTERPRISES]2
coconut oilINACTIVE INGREDIENTQ9L0O73W7LANALGESIC (MENTHOL) SPRAY [PREMIERE ENTERPRISES]2
eucalyptus oilINACTIVE INGREDIENT2R04ONI662ANALGESIC (MENTHOL) SPRAY [PREMIERE ENTERPRISES]2
eucalyptus oilINACTIVE INGREDIENT2R04ONI662PREMIERES PAIN (MENTHOL) SPRAY [PREMIERE ENTERPRISES]2
eucalyptus oilINACTIVE INGREDIENT2R04ONI662PREMIERE PAIN ROLL ON (MENTHOL) SPRAY [PREMIERE ENTERPRISES]2
glycerinINACTIVE INGREDIENTPDC6A3C0OXANALGESIC (MENTHOL) SPRAY [PREMIERE ENTERPRISES]2
glycerinINACTIVE INGREDIENTPDC6A3C0OXPREMIERES PAIN (MENTHOL) SPRAY [PREMIERE ENTERPRISES]2
glycerinINACTIVE INGREDIENTPDC6A3C0OXPREMIERE PAIN ROLL ON (MENTHOL) SPRAY [PREMIERE ENTERPRISES]2
isopropyl alcoholINACTIVE INGREDIENTND2M416302PREMIERES PAIN (MENTHOL) SPRAY [PREMIERE ENTERPRISES]2
isopropyl alcoholINACTIVE INGREDIENTND2M416302PREMIERE PAIN ROLL ON (MENTHOL) SPRAY [PREMIERE ENTERPRISES]2
isopropyl alcoholINACTIVE INGREDIENTND2M416302ANALGESIC (MENTHOL) SPRAY [PREMIERE ENTERPRISES]2
methyl salicylateINACTIVE INGREDIENTLAV5U5022YANALGESIC (MENTHOL) SPRAY [PREMIERE ENTERPRISES]2
methyl salicylateINACTIVE INGREDIENTLAV5U5022YPREMIERES PAIN (MENTHOL) SPRAY [PREMIERE ENTERPRISES]2
methyl salicylateINACTIVE INGREDIENTLAV5U5022YPREMIERE PAIN ROLL ON (MENTHOL) SPRAY [PREMIERE ENTERPRISES]2
peppermint oilINACTIVE INGREDIENTAV092KU4JHPREMIERE PAIN ROLL ON (MENTHOL) SPRAY [PREMIERE ENTERPRISES]2
peppermint oilINACTIVE INGREDIENTAV092KU4JHPREMIERES PAIN (MENTHOL) SPRAY [PREMIERE ENTERPRISES]2
peppermint oilINACTIVE INGREDIENTAV092KU4JHANALGESIC (MENTHOL) SPRAY [PREMIERE ENTERPRISES]2
waterINACTIVE INGREDIENT059QF0KO0RANALGESIC (MENTHOL) SPRAY [PREMIERE ENTERPRISES]2
waterINACTIVE INGREDIENT059QF0KO0RPREMIERE PAIN ROLL ON (MENTHOL) SPRAY [PREMIERE ENTERPRISES]2
waterINACTIVE INGREDIENT059QF0KO0RPREMIERES PAIN (MENTHOL) SPRAY [PREMIERE ENTERPRISES]2
xanthan gumINACTIVE INGREDIENTTTV12P4NEEPREMIERE PAIN ROLL ON (MENTHOL) SPRAY [PREMIERE ENTERPRISES]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
32472-102PREMIERES PAIN (MENTHOL) SPRAY [PREMIERE ENTERPRISES]5Current NDC, Legacy NDC, 1 package rows20241225_128bd1e7-e961-416c-933b-fbd146e3d386.zip
32472-102PREMIERES PAIN (MENTHOL) SPRAY [PREMIERE ENTERPRISES]5Current NDC, Legacy NDC, 1 package rows20241225_1f081913-6106-4d06-a37a-631f710dbacb.zip
32472-102PREMIERES PAIN (MENTHOL) SPRAY [PREMIERE ENTERPRISES]5Current NDC, Legacy NDC, 1 package rows20241225_35ff19df-4cc4-4fce-bd30-d87d835e0e26.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 125 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
terrasil Bruise and Pain Relief Maximum StrengthCAMPHOR, MENTHOLAidance Scientific, Inc., DBA Aidance Skincare & Topical Solutions240b231d-a8b2-c64c-e063-6394a90a74402024-10-09WarningsExact identifier
application number: M017
Muscle Freeze ReliefMENTHOLNATURAL ESSENTIALS, INC.815c534b-096d-49f2-b5f2-8c885d45a5e62024-10-09WarningsExact identifier
application number: M017
HYDROCORTISONEHYDROCORTISONEVIVE HEALTH LLC2410dc2f-9332-19fa-e063-6394a90a28352024-10-09WarningsExact identifier
application number: M017
CVS Health Lidocaine Pain-RelievingLIDOCAINENatural Essentials, Inc.fc23b2e2-4abc-4119-b8bd-305b4327f1dd2024-10-09WarningsExact identifier
application number: M017
KERACAREMENTHOL 1%Avlon Industries, Inc.f72eec6d-1204-4e03-8aed-d5bcf8d3bbce2024-10-09WarningsExact identifier
application number: M017
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1086713menthol 7 % Topical SprayPSN128bd1e7-e961-416c-933b-fbd146e3d3866
1086713menthol 7 % Topical SprayPSN1f081913-6106-4d06-a37a-631f710dbacb6
1086713menthol 7 % Topical SprayPSN35ff19df-4cc4-4fce-bd30-d87d835e0e266
1086713menthol 70 MG/ML Topical SpraySCD128bd1e7-e961-416c-933b-fbd146e3d3866
1086713menthol 70 MG/ML Topical SpraySCD1f081913-6106-4d06-a37a-631f710dbacb6
1086713menthol 70 MG/ML Topical SpraySCD35ff19df-4cc4-4fce-bd30-d87d835e0e266
1086713menthol 7 % Topical SpraySY128bd1e7-e961-416c-933b-fbd146e3d3866
1086713menthol 7 % Topical SpraySY1f081913-6106-4d06-a37a-631f710dbacb6
1086713menthol 7 % Topical SpraySY35ff19df-4cc4-4fce-bd30-d87d835e0e266

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
32472-102-013247201020129.5 mL in 1 BOTTLE (32472-102-01) 29.5 ml2011-03-070000-00-00NoNoCurrent
32472-102-033247201020388 mL in 1 BOTTLE (32472-102-03) 88 ml2011-01-120000-00-00NoNoCurrent
32472-102-0432472010204118 mL in 1 BOTTLE (32472-102-04) 118 ml2010-12-280000-00-00NoNoCurrent