FDA.reportPublic FDA data

Antiseptic Instant Pain Relief

Product NDC
82645-902
11-digit product format
826450902
Labeler code
82645
Product ID
82645-902_0d1cd55e-cd94-6e7e-e063-6294a90ae7a5
Type
HUMAN OTC DRUG
Nonproprietary name
Camphor 10.8% and Phenol 4.7%
Dosage form
LIQUID
Route
TOPICAL
Labeler
Pharma Nobis, LLC
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2017-11-09
Substance
CAMPHOR (NATURAL); PHENOL
Active strength
108; 47 mg/mL; mg/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
Antiseptic Instant Pain Relief
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CAMPHOR (NATURAL)108 mg/mL
PHENOL47 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
N20HL7Q941Internal UNII lookup
339NCG44TVInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
308940Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
e42f484d-a642-3489-e053-2a95a90a4254Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82645-902-05Antiseptic Instant Pain Relief45 mL in 1 BOTTLE, GLASSLIQUID452

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82645-902ANTISEPTIC INSTANT PAIN RELIEF (CAMPHOR 10.8% AND PHENOL 4.7%) LIQUID [PHARMA NOBIS, LLC]2Current NDC, 1 package rows20231223_e42f484d-a642-3489-e053-2a95a90a4254.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 17 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MyDerm Aloe and LidocaineLIDOCAINEMedline Industriesfdfd4388-cd27-467b-959b-249a49ea5cf62026-05-26WarningsExact identifier
application number: M017
MyDerm Aloe and LidocaineLIDOCAINEInspec Solutions LLC.4939c663-a876-4527-822a-df02964fa6942026-05-26WarningsExact identifier
application number: M017
Lidocaine Menthol Pain ReliefLIDOCAINE, MENTHOLAmerisource Bergen94039190-dde3-4d8e-873a-79abd3f6208b2026-05-26WarningsExact identifier
application number: M017
topcare hydrocortisoneHYDROCORTISONETopco Associates LLC858053a0-d888-4bb9-b94e-503bcf3864cb2026-05-21WarningsExact identifier
application number: M017
Arthritis Pain Relief CreamHISTAMINE DIHYDROCHLORIDESombra Cosmetics Inc.523333ee-eccd-bcf7-e063-6394a90aea602026-05-21WarningsExact identifier
application number: M017
North Star Nutritionals Soothanol X3 Pain Relieving DropsMENTHOLNEWMARKET HEALTH PRODUCTS, LLC068343b8-0435-40d0-846c-9d8624e8b6c42026-05-21WarningsExact identifier
application number: M017
DO ME DELAYLIDOCAINE HCLProdigy Media Inc5255ee85-6f29-0776-e063-6394a90a525b2026-05-21WarningsExact identifier
application number: M017
Australian Dream Back PainHISTAMINE DIHYDROCHLORIDESombra Cosmetics Inc.5256a63e-e6da-84c1-e063-6294a90a8dff2026-05-21WarningsExact identifier
application number: M017
SINSIN HANBANG FLEXCAMPHOR, MENTHOLSinsin Pharmaceutical co., ltd.525c5d18-bfc1-3002-e063-6394a90a5b1d2026-05-21WarningsExact identifier
application number: M017
LidoPro PatchLIDOCAINE, MENTHOL, AND METHYL SALICYLATEPreferred Pharmaceuticals Inc.6c9a076e-6316-427b-9ce6-c8fe2d3888372026-05-21WarningsExact identifier
application number: M017
Medi-First Capsaicin CreamCAPSAICINUnifirst First Aid Corporation49eb807b-fa31-3d84-e063-6394a90acfcf2026-05-20WarningsExact identifier
application number: M017
Biofreeze Triple Target Roll-OnCAMPHOR, CAPSAICIN, MENTHOLReckitt Benckiser LLC5089c088-3026-233a-e063-6394a90a93b62026-05-19WarningsExact identifier
application number: M017
Lidocaine Pain Relief PatchLIDOCAINEGERI-CARE PHARMACEUTICAL CORP522f1521-f9f2-4c26-e063-6394a90a9e052026-05-19WarningsExact identifier
application number: M017
Easment 0.1% Capsaicin Roll onCAPSAICIN 0.1%Easment LLC521212d6-57fd-4a7a-e063-6294a90a2a182026-05-18WarningsExact identifier
application number: M017
Burn ReliefLIDOCAINEWALMART INC.15af4557-4baf-c177-e063-6294a90a7a5b2026-05-18WarningsExact identifier
application number: M017
Blistex Maximum Hydration LipCAMPHOR (SYNTHETIC), DIMETHICONE, UNSPECIFIED, MENTHOL, UNSPECIFIED FORM, AND PHENOLBlistex Inc.fed223bc-edf3-46eb-b678-acb906f9ef112026-05-18WarningsExact identifier
application number: M017
Tiger BalmCAMPHOR (SYNTHETIC), MENTHOL, AND CAPSICUMHaw Par Healthcare Ltd.5066dc10-e4d5-49e9-9a5f-0ac220cfbf282026-05-18WarningsExact identifier
application number: M017
Deep Blue MiniMENTHOLdoTERRA International, LLC51dd58a8-1fd5-9cd7-e063-6394a90a1f722026-05-15WarningsExact identifier
application number: M017
Biofreeze Overnight GelMENTHOLReckitt Benckiser LLCf5c8c08b-c7c0-f84d-e053-2a95a90add152026-05-15WarningsExact identifier
application number: M017
Biofreeze ProfessionalMENTHOL, UNSPECIFIED FORMReckitt Benckiser LLC00bba5d2-b0e0-701c-e063-6294a90a57412026-05-15WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308940camphor 10.8 % / phenol 4.7 % Topical SolutionPSNe42f484d-a642-3489-e053-2a95a90a42542
308940camphor 108 MG/ML / phenol 47 MG/ML Topical SolutionSCDe42f484d-a642-3489-e053-2a95a90a42542
308940camphor 10.8 % / phenol 4.7 % Topical SolutionSYe42f484d-a642-3489-e053-2a95a90a42542

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
82645-902-058264509020545 mL in 1 BOTTLE, GLASS (82645-902-05) 45 ml2017-11-09NoNoCurrent