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 118 of 151 · 3,010 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Real Time Pain Relief Maxx Plus Topical AnalgesicMENTHOLReal Time Products Inc.fc509a55-594d-4d44-87db-33286e9375812024-11-12WarningsExact identifier
application number: M017
Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEAcme United Corporationf1f051ad-7e82-9d1a-e053-2a95a90ac7d32024-11-12WarningsExact identifier
application number: M017
HYDROCORTISONEHYDROCORTISONEALLIED TRADE LINK LLC26bc238d-3bda-0c29-e063-6394a90a35fb2024-11-12WarningsExact identifier
application number: M017
HydrocortisoneHYDROCORTISONEAcme United Corporationfabcaa3b-d189-bd29-e053-6294a90ae86b2024-11-12WarningsExact identifier
application number: M017
ActivICEMENTHOLMedline Industries, LP8414aea2-52b5-4221-e053-2a91aa0a622e2024-11-12WarningsExact identifier
application number: M017
Pain Relieving Gel-PatchLIDOCAINEShanghai Chuangshi Medical Technology (Group) Co., Ltd.26c7116f-c86d-8752-e063-6294a90ab73f2024-11-12WarningsExact identifier
application number: M017
HydrocortisoneHYDROCORTISONEKroger Companyfc1677f2-4078-4ebd-9c3b-86a29a35b4892024-11-12WarningsExact identifier
application number: M017
CVS Health Lidocaine CreamLIDOCAINECVS Healthad950680-c03c-4fa5-aa7f-239a889cd0972024-11-12WarningsExact identifier
application number: M017
CVS Arthritis Pain ReliefARTHRITIS PAIN RELIEFCVS Health575dd514-fd99-4e44-8fc8-52938f9abc262024-11-11WarningsExact identifier
application number: M017
ThermaPatch (TM) Lidocaine Pain Relief PatchLIDOCAINE PAIN RELIEF PATCHHenan Enokon Medical Instrument Co., Ltd.26769590-cd50-1b01-e063-6394a90a445c2024-11-09WarningsExact identifier
application number: M017
DG Health Cold Zone Pain Relieving Topical AnalgesicMENTHOL, UNSPECIFIED FORMDolgencorp Inc22594ab8-9a4a-426f-aced-5c636620fa2c2024-11-08WarningsExact identifier
application number: M017
Peviderm Pramoxine Hydrocholride 1%PRAMOXINE HYDROCHLORIDEStratus Pharmaceuticals Inc680b40fa-1922-443a-a4b0-7c3f6a2b847d2024-11-07WarningsExact identifier
application number: M017
Meijer Analgesic with Aloe Topical AnalgesicTROLAMINE SALICYLATEMeijer Distribution, Incf6c1e09e-4c61-4c2a-87d7-b052ed36fcac2024-11-07WarningsExact identifier
application number: M017
Meijer Pain Relieving Balm AnalgesicTROLAMINE SALICYLATEMeijer Distribution, Inc1b7535cc-01ac-49f0-9889-dd14b254d4ae2024-11-07WarningsExact identifier
application number: M017
BENGAY Tropical JasmineLIDOCAINEKenvue Brands LLCc416320a-c0d7-401e-b0fa-44114d76a5572024-11-06WarningsExact identifier
application number: M017
Bengay Ultra Strength Large SizeMENTHOL, UNSPECIFIED FORMKenvue Brands LLCf57ccc33-400b-4401-a348-c54d1eb9f5d02024-11-06WarningsExact identifier
application number: M017
Band Aid Antiseptic Cleansing To GoBENZALKONIUM CHLORIDE, PRAMOXINE HCLKenvue Brands LLCd5749cba-32f3-cf9c-e053-2a95a90a44162024-11-06WarningsExact identifier
application number: M017
Pain Relieving CreamCAMPHOR AND MENTHOLGOLDEN TIGER DISTRIBUTION L.L.C.26473383-282c-fb10-e063-6394a90a5fa22024-11-06WarningsExact identifier
application number: M017
Pain Relieving CreamCAMPHOR AND MENTHOLGOLDEN TIGER DISTRIBUTION L.L.C.1b6f929a-db65-8a02-e063-6394a90a8b592024-11-06WarningsExact identifier
application number: M017
Meijer Maximum Strength Pain Relieving AnalgesicMENTHOL, UNSPECIFIED FORMMeijer Distribution, Incbd6f04f9-a23b-45f6-bce2-1ef7203198e12024-11-06WarningsExact 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