FDA.reportPublic FDA data

Nervive Pain Relieving

Product NDC
84126-317
11-digit product format
841260317
Labeler code
84126
Product ID
84126-317_5d1bcf95-daf5-30c1-e063-6394a90a9670
Type
HUMAN OTC DRUG
Nonproprietary name
Lidocaine HCl and Menthol
Dosage form
LIQUID
Route
TOPICAL
Labeler
The Procter & Gamble Manufacturing Company
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-08-12
Substance
LIDOCAINE HYDROCHLORIDE ANHYDROUS; MENTHOL
Active strength
4; 1 g/100g; g/100g
Pharmacologic classes
Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]
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
Nervive Pain Relieving
Brand name suffix
Liquid Roll-on
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LIDOCAINE HYDROCHLORIDE ANHYDROUS4 g/100g
MENTHOL1 g/100g

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
070fbed5-7088-434a-a7ce-f2a64d8d40acProduct name220260107
bee66ce1-adb7-9d3b-67d9-582e4c54e80fProduct name520250819
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
7d755fa1-1087-4dcd-98f0-6d4bba479a57Product name320210602
aed701d5-9c75-dfaf-7154-cde46179faeaProduct name920200313
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
332d03e4-aa24-4b11-841a-02bf41081920Product name120171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
68ed98f8-24c2-44a0-944a-6d36e82ce25aProduct name120141222
1cd42bc2-a430-c72b-636d-991b235fbf80Product name120140508
49fa150c-f0de-cce7-3d9c-993ed81c5698Product name120140508
4d7ae718-ed00-bae8-2abe-9eaec1eef7ffProduct name120140508
9137811f-f279-8640-5aeb-99fa2145d64dProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84126-317-03Nervive Pain RelievingLiquid Roll-on1 in 1 CARTONLIQUID16
84126-317-03Nervive Pain RelievingLiquid Roll-on70.9 g in 1 BOTTLELIQUID70.96
84126-317-05Nervive Pain RelievingLiquid Roll-on130.4 g in 1 BOTTLELIQUID130.46
84126-317-05Nervive Pain RelievingLiquid Roll-on1 in 1 CARTONLIQUID16
84126-317-25Nervive Pain RelievingLiquid Roll-on70.9 g in 1 BOTTLE, WITH APPLICATORLIQUID70.96
84126-317-25Nervive Pain RelievingLiquid Roll-on1 in 1 CARTONLIQUID16
84126-317-46Nervive Pain RelievingLiquid Roll-on130.4 g in 1 BOTTLE, WITH APPLICATORLIQUID130.46
84126-317-46Nervive Pain RelievingLiquid Roll-on1 in 1 CARTONLIQUID16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84126-317NERVIVE PAIN RELIEVING LIQUID ROLL-ON (LIDOCAINE HCL AND MENTHOL) LIQUID [THE PROCTER & GAMBLE MANUFACTURING COMPANY]4Current NDC, 8 package rows20250206_1e8aeccc-8d00-9886-e063-6394a90ad7a6.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 19 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Biofreeze MentholMENTHOL, UNSPECIFIED FORMReckitt Benckiser LLC3f2b1f48-2d78-4985-a046-9f72de5e1a9b2026-05-13WarningsExact identifier
application number: M017
BiofreezeMENTHOLReckitt Benckiser LLC10a8face-47da-ebbe-e063-6294a90a42fe2026-05-13WarningsExact identifier
application number: M017
Biofreeze Foot CreamMENTHOLReckitt Benckiser LLC32450cbf-4ed4-402b-a30e-e08a17bba3fb2026-05-13WarningsExact identifier
application number: M017
BiofreezeMENTHOLReckitt Benckiser LLCa227213b-e89f-7144-e053-2a95a90a7e742026-05-13WarningsExact identifier
application number: M017
BiofreezeMENTHOLReckitt Benckiser LLC00bb462a-27d0-6f74-e063-6394a90a90ec2026-05-13WarningsExact identifier
application number: M017
BioFreeze Dry StickMENTHOLReckitt Benckiser LLC26d62cd2-9209-8cca-e063-6394a90a20282026-05-13WarningsExact identifier
application number: M017
Biofreeze Foot Pain Relief SetMENTHOLReckitt Benckiser LLC4a885eef-0364-4655-bccc-7158c76cc5b22026-05-13WarningsExact identifier
application number: M017
Biofreeze Colorless Roll-OnMENTHOLReckitt Benckiser LLCa8d59d45-0e85-43d1-affd-bbe922c4acb12026-05-13WarningsExact identifier
application number: M017
Biofreeze ColorlessMENTHOLReckitt Benckiser LLC939dbbc3-71ec-4990-840e-7c9b8d4305622026-05-13WarningsExact identifier
application number: M017
Biofreeze Flexible Relief StripMENTHOLReckitt Benckiser LLC6ec26bae-e395-49aa-969e-8c653d6f0b272026-05-13WarningsExact identifier
application number: M017
Biofreeze Day and OvernightMENTHOLReckitt Benckiser LLCfb5c8f89-a720-ad32-e053-6294a90a2abe2026-05-13WarningsExact identifier
application number: M017
Biofreeze FoamMENTHOLReckitt Benckiser LLC890191e8-99ad-489c-8f21-2592f3d319362026-05-13WarningsExact identifier
application number: M017
Orajel Cold Sore Touch Free - Single DoseBENZALKONIUM CHLORIDE, BENZOCAINEChurch & Dwight Co., Inc.ce40829e-941f-2548-e053-2995a90a1e0e2026-05-13WarningsExact identifier
application number: M017
Lidocaine Pain Relief PatchLIDOCAINEGERI-CARE PHARMACEUTICAL CORP51b7753b-8619-6ea9-e063-6294a90a4ea42026-05-13WarningsExact identifier
application number: M017
DERMFREE Anti-itch CreamHYDROCORTISONE1% ANTI-ITCH CREAMJiangxi Zhongletang Pharmaceuticals Co.,Ltd.519c319a-9c43-0e63-e063-6394a90ab8692026-05-13WarningsExact identifier
application number: M017
Valtrum TOPICAL ANALGESICCAMPHOR, MENTHOL, METHYL SALICYLATELaboratorios Quantium LLCf3c4cc3a-f3a3-4d02-97e0-9c3fc1a67c3e2026-05-13WarningsExact identifier
application number: M017
Biofreeze Professional ColorlessMENTHOL, UNSPECIFIED FORMReckitt Benckiser4639201c-a67a-475f-8df6-3dc6225803ad2026-05-12WarningsExact identifier
application number: M017
Biofreeze Professional Colorless Roll-OnMENTHOL, UNSPECIFIED FORMReckitt Benckiser LLCbae9946a-4c68-4759-9fb3-0a61a7ad0eb72026-05-12WarningsExact identifier
application number: M017
Instaflex Pain Relief CreamMENTHOLHealthy Directions, LLC665b847a-9cfb-49fc-975b-81c97f9365752026-05-12WarningsExact identifier
application number: M017
Theracare Cold Therapy Pain ReliefMENTHOLVeridian Healthcare51a5a043-07b6-1c96-e063-6394a90aa9262026-05-12WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2002008lidocaine HCl 4 % / menthol 1 % Topical SolutionPSN1e8aeccc-8d00-9886-e063-6394a90ad7a66
2002008lidocaine hydrochloride 40 MG/ML / menthol 10 MG/ML Topical SolutionSCD1e8aeccc-8d00-9886-e063-6394a90ad7a66
2002008lidocaine HCl 4 % / menthol 1 % Topical SolutionSY1e8aeccc-8d00-9886-e063-6394a90ad7a66

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
84126-317-03841260317031 BOTTLE in 1 CARTON (84126-317-03) / 70.9 g in 1 BOTTLE1 bottle2024-08-122028-06-01NoNoHistorical
84126-317-05841260317051 BOTTLE in 1 CARTON (84126-317-05) / 130.4 g in 1 BOTTLE1 bottle2025-03-182028-06-01NoNoHistorical
84126-317-25841260317251 BOTTLE, WITH APPLICATOR in 1 CARTON (84126-317-25) / 70.9 g in 1 BOTTLE, WITH APPLICATOR2026-06-01NoNoCurrent
84126-317-46841260317461 BOTTLE, WITH APPLICATOR in 1 CARTON (84126-317-46) / 130.4 g in 1 BOTTLE, WITH APPLICATOR2026-06-01NoNoCurrent