FDA.reportPublic FDA data

Coralite Ultra Strength Pain Relief

Product NDC
65923-532
11-digit product format
659230532
Labeler code
65923
Product ID
65923-532_425530d6-e8ea-f05c-e063-6294a90aff39
Type
HUMAN OTC DRUG
Nonproprietary name
Camphor Menthol
Dosage form
OINTMENT
Route
TOPICAL
Labeler
United Exchange Corp.
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2014-10-15
Substance
CAMPHOR (SYNTHETIC); MENTHOL
Active strength
110; 110 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
Coralite Ultra Strength Pain Relief
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CAMPHOR (SYNTHETIC)110 mg/g
MENTHOL110 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
5TJD82A1ETInternal UNII lookup
L7T10EIP3AInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1089831Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
44ecf959-cc07-4adc-a500-075b2ee69548Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
EffectiveRelated label
2022-03-31Coralite Ultra Strength Pain Relief Balm 0.63oz (532)
2022-03-31Coralite Ultra Strength Pain Relief Balm 0.63oz (532)
2022-01-28Coralite Ultra Strength Pain Relief Balm 0.63oz (532)
2022-01-28Coralite Ultra Strength Pain Relief Balm 0.63oz (532)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65923-532-18Coralite Ultra Strength Pain Relief1 in 1 CARTONOINTMENT113
65923-532-18Coralite Ultra Strength Pain Relief18 g in 1 JAROINTMENT1813

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CAMPHOR (SYNTHETIC)ACTIVE INGREDIENT5TJD82A1ETCORALITE ULTRA STRENGTH PAIN RELIEF (CAMPHOR MENTHOL) OINTMENT [UNITED EXCHANGE CORP.]1
MENTHOLACTIVE INGREDIENTL7T10EIP3ACORALITE ULTRA STRENGTH PAIN RELIEF (CAMPHOR MENTHOL) OINTMENT [UNITED EXCHANGE CORP.]1
CAMPHOR (SYNTHETIC)ACTIVE MOIETY5TJD82A1ETCORALITE ULTRA STRENGTH PAIN RELIEF (CAMPHOR MENTHOL) OINTMENT [UNITED EXCHANGE CORP.]1
MENTHOLACTIVE MOIETYL7T10EIP3ACORALITE ULTRA STRENGTH PAIN RELIEF (CAMPHOR MENTHOL) OINTMENT [UNITED EXCHANGE CORP.]1
CAJUPUT OILINACTIVE INGREDIENTJ3TO6BUQ37CORALITE ULTRA STRENGTH PAIN RELIEF (CAMPHOR MENTHOL) OINTMENT [UNITED EXCHANGE CORP.]1
CLOVE OILINACTIVE INGREDIENT578389D6D0CORALITE ULTRA STRENGTH PAIN RELIEF (CAMPHOR MENTHOL) OINTMENT [UNITED EXCHANGE CORP.]1
PARAFFININACTIVE INGREDIENTI9O0E3H2ZECORALITE ULTRA STRENGTH PAIN RELIEF (CAMPHOR MENTHOL) OINTMENT [UNITED EXCHANGE CORP.]1
PETROLATUMINACTIVE INGREDIENT4T6H12BN9UCORALITE ULTRA STRENGTH PAIN RELIEF (CAMPHOR MENTHOL) OINTMENT [UNITED EXCHANGE CORP.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65923-532CORALITE ULTRA STRENGTH PAIN RELIEF (CAMPHOR MENTHOL) OINTMENT [UNITED EXCHANGE CORP.]11Current NDC, Legacy NDC, 2 package rows20241222_44ecf959-cc07-4adc-a500-075b2ee69548.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 151 · 3,010 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
equaline anti itch maximum strengthHYDROCORTISONEUnited Natural Foods, Inc. dba UNFI070000d7-7d4d-439b-9a91-851ba7c027e62024-10-03WarningsExact identifier
application number: M017
hydrocortisone anti itchHYDROCORTISONEH E Ba1a9fed8-4938-48b5-81f1-d3942d534bb82024-10-03WarningsExact identifier
application number: M017
equaline anti itchHYDROCORTISONEUnited Natural Foods, Inc. dba UNFIef9ea069-9b97-4bf5-aaac-deb85334dbd02024-10-03WarningsExact identifier
application number: M017
Basic Care HydrocortisoneHYDROCORTISONEAmazon.com Services LLC7fa13ab4-5f2d-4a48-816f-1b22d5f757b22024-10-03WarningsExact identifier
application number: M017
hydrocortisoneHYDROCORTISONEA-S Medication Solutionsdc388dc1-0c4f-4bf1-8a12-fa39892317bc2024-10-02WarningsExact identifier
application number: M017
Geliga MuscularMENTHOL, METHYL SALICYLATEPT. EAGLE INDO PHARMAfb2beb08-0ad6-a89d-e053-6294a90aa6fe2024-10-02WarningsExact identifier
application number: M017
Geliga Muscular BalmMENTHOL, METHYL SALICYLATEPT. EAGLE INDO PHARMAda28097f-4b5c-6159-e053-2a95a90a7d962024-10-02WarningsExact identifier
application number: M017
CircatrixCAPSAICINPureTek Corporationcd3b1256-2df8-dc26-e053-2a95a90ad0492024-10-02WarningsExact identifier
application number: M017
DermacinRx Penetral CreamCAPSAICINPureTek Corporation1e343a52-6071-3230-e054-00144ff8d46c2024-10-02WarningsExact identifier
application number: M017
Eagle Medicated AromaticCAMPHOR MENTHOL METHYL SALICYLATEBorden Company (Private) Limited36abfc2c-d424-4df8-968d-866342c96a562024-10-02WarningsExact identifier
application number: M017
Eagle BalmCAMPHOR MENTHOLEagle Indo Pharma, PT87614869-9675-2c76-e053-2a95a90a48a92024-10-02WarningsExact identifier
application number: M017
Eagle MedicatedMENTHOL METHYL SALICYLATEBorden Company (Private) Limitedd9a93daa-4e24-6690-e053-2a95a90a147c2024-10-02WarningsExact identifier
application number: M017
Eagle Extra StrengthMENTHOL METHYL SALICYLATEBorden Company (Private) Limited5e02fbe3-5bc7-430e-b661-3a760ddd8fe02024-10-02WarningsExact identifier
application number: M017
Eagle Medicated Oil RefreshingMENTHOL, METHYL SALICYLATEBorden Company (Private) Limitedc62a4313-2c07-5f58-e053-2995a90a083a2024-10-02WarningsExact identifier
application number: M017
Eagle Medicated AromaticCAMPHOR MENTHOL METHYL SALICYLATEEagle Indo Pharma, PTe272ec90-3cd9-5b70-e053-2a95a90a1df42024-10-02WarningsExact identifier
application number: M017
RUGBY HYDROCORTISONE WITH ALOEHYDROCORTISONEA-S Medication Solutionsb2674075-aaa4-4c77-bcaa-a76336b3c3212024-10-02WarningsExact identifier
application number: M017
Herb Street Anti-Itch StickHYDROCORTISONEBalassa Laboratories Inc.8717faae-59c3-4c6f-9ef1-285c0d2445ed2024-10-01WarningsExact identifier
application number: M017
Herb Street Backache and Sore Muscle ReliefMENTHOLBalassa Laboratories Inc.aeac1b64-8689-4b3d-a41c-db41061257b52024-10-01WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1089831camphor 11 % / menthol 11 % Topical CreamPSN44ecf959-cc07-4adc-a500-075b2ee6954813
1089831camphor 110 MG/ML / menthol 110 MG/ML Topical CreamSCD44ecf959-cc07-4adc-a500-075b2ee6954813
1089831camphor 11 % / menthol 11 % Topical CreamSY44ecf959-cc07-4adc-a500-075b2ee6954813

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65923-532-18659230532181 JAR in 1 CARTON (65923-532-18) / 18 g in 1 JAR1 jar2017-12-130000-00-00NoNoCurrent