FDA.reportPublic FDA data

BENGAY ULTRA STRENGTH NON-GREASY

Product NDC
69968-0538
11-digit product format
699680538
Labeler code
69968
Product ID
69968-0538_28fcca55-7990-dba5-e063-6294a90aac6a
Type
HUMAN OTC DRUG
Nonproprietary name
CAMPHOR (SYNTHETIC), MENTHOL, UNSPECIFIED FORM, and Methyl Salicylate
Dosage form
CREAM
Route
TOPICAL
Labeler
Kenvue Brands LLC
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2018-06-01
Substance
CAMPHOR (SYNTHETIC); MENTHOL, UNSPECIFIED FORM; METHYL SALICYLATE
Active strength
40; 100; 300 mg/g; 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
BENGAY ULTRA STRENGTH NON-GREASY
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CAMPHOR (SYNTHETIC)40 mg/g
MENTHOL, UNSPECIFIED FORM100 mg/g
METHYL SALICYLATE300 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
5TJD82A1ETInternal UNII lookup
L7T10EIP3AInternal UNII lookup
LAV5U5022YInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
283083Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
0a41ec65-bd0b-4fc6-807d-74f353341cc7Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69968-0538-2BENGAY ULTRA STRENGTH NON-GREASY1 in 1 CARTONCREAM19
69968-0538-2BENGAY ULTRA STRENGTH NON-GREASY57 g in 1 TUBECREAM579
69968-0538-4BENGAY ULTRA STRENGTH NON-GREASY113 g in 1 TUBECREAM1139
69968-0538-4BENGAY ULTRA STRENGTH NON-GREASY1 in 1 CARTONCREAM19
69968-0538-5BENGAY ULTRA STRENGTH NON-GREASY2 in 1 CARTONCREAM29
69968-0538-5BENGAY ULTRA STRENGTH NON-GREASY113 g in 1 TUBECREAM1139

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69968-0538BENGAY ULTRA STRENGTH NON-GREASY (CAMPHOR (SYNTHETIC), MENTHOL, UNSPECIFIED FORM, AND METHYL SALICYLATE) CREAM [KENVUE BRANDS LLC]9Current NDC, Legacy NDC, 6 package rows20241215_0a41ec65-bd0b-4fc6-807d-74f353341cc7.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 33 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hemp Magic Fast-Acting Pain Relief CreamMENTHOLNexxus Capital LLC4af69640-1413-868b-e063-6394a90a39892026-02-16WarningsExact identifier
application number: M017
RelaxInk LIDOCAINELIDOCAINE 4%Hambli Limited49a1cf66-9bb1-b918-e063-6394a90a2ff62026-02-15WarningsExact identifier
application number: M017
blue goo Pain RelievingMENTHOL 2.5%Garcoa, Inc.7b9b5ac6-9568-464c-8096-0302a1e650df2026-02-13WarningsExact identifier
application number: M017
Methyl Salicylate 30 Percent CreamMETHYL SALICYLATEAlexso, Inc1d50ccb2-1a5d-49c7-8524-2f54eed63e852026-02-13WarningsExact identifier
application number: M017
Antiseptic Mouth RinseEUCALYPTOL, MENTHOL, METHYOL SALICYLATE, THYMOLTopco Associates LLCa38e91c1-7ac6-4a7f-a5a2-8d9166b1535a2026-02-13Warnings, Adverse reactionsExact identifier
application number: M017
Gel Cooling Pain ReliefMENTHOLTopco Associates LLC80962394-a46f-48fd-8e0c-685dd1e500d72026-02-13Warnings, Adverse reactionsExact identifier
application number: M017
BanophenDIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATEMajor Pharmaceuticals9758d886-bd58-4eb2-a827-fa8e7fee2b7c2026-02-13WarningsExact identifier
application number: M017
Natureplex Hydrocortisone HydroHYDROCORTISONENatureplex, LLC2fc6a148-34bb-4289-8588-32c1bb011b982026-02-13WarningsExact identifier
application number: M017
Capsaicin 0.035 PercentCAPSAICINAlexso, Inc6d0bc1cc-e812-4753-b20c-c0357dd6deb52026-02-13WarningsExact identifier
application number: M017
Swiftalyn Numbing CreamLIDOCAINE 4%GENUINE INNOVATION LTD3f74c4a6-26f0-ddf7-e063-6394a90a12252026-02-12WarningsExact identifier
application number: M017
PHARMBANNER Arnica Bruise CreamARNICA BRUISE CREAMShenzhen Xinxin Yunhai Technology Co., Ltd.3c783061-8e2d-8a84-e063-6394a90a52652026-02-12WarningsExact identifier
application number: M017
ETERNAL SPIRIT BEAUTY PAIN RELIEF WITH HEMPMENTHOL, CAMPHORWorldwide Cosmetics, Inc459d64a9-0538-57c8-e063-6394a90a61552026-02-12WarningsExact identifier
application number: M017
Antiseptic Mouth RinseEUCALYPTOLWalgreen Co.cba60e9d-5f12-4c56-9fa5-6ce1514fc2b02026-02-12Warnings, Adverse reactionsExact identifier
application number: M017
Medicated Body PowderMENTHOLWalmart Stores Incafd337b7-d76e-f17a-e053-2a95a90abac72026-02-12WarningsExact identifier
application number: M017
Lidocaine Hydrochloride 2%LIDOCAINE HYDROCHLORIDEAldermed Inc.4977b722-d08d-3d9e-e063-6294a90a90352026-02-12WarningsExact identifier
application number: M017
Ice Gel ICE COLD ANALGESICMENTHOLJell Pharmaceuticals Pvt Ltd4a8b3f84-8c45-eb94-e063-6394a90a3e732026-02-11WarningsExact identifier
application number: M017
Walgreens Pain Relieving Lidocaine PatchLIDOCAINEWalgreen Co.41c4e9fe-e407-b22a-e063-6394a90a4b272026-02-10WarningsExact identifier
application number: M017
HydrocortisoneHYDROCORTISONE CREAM 1%Aldermed Inc.4a7f2c0e-5cf3-29cb-e063-6394a90a5d8d2026-02-10WarningsExact identifier
application number: M017
MENTHOL, CAMPHORMENTHOL, CAMPHORSUNSET PAIN RELIEF4a7f92d3-dd35-44a3-e063-6294a90ae0042026-02-10WarningsExact identifier
application number: M017
NICOVITO HEMORRHOID MASTERLIDOCAINE 4% PHENYLEPHRINE HCL 0.25% HEMORRHOID MASTERJiangxi Yudexi Pharmaceutical Co., LTD4a5e24fa-959e-79b4-e063-6294a90a8f682026-02-09WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
283083camphor 4 % / menthol 10 % / methyl salicylate 30 % Topical CreamPSN0a41ec65-bd0b-4fc6-807d-74f353341cc79
283083camphor 40 MG/ML / menthol 100 MG/ML / methyl salicylate 300 MG/ML Topical CreamSCD0a41ec65-bd0b-4fc6-807d-74f353341cc79
283083camphor 4 % / menthol 10 % / methyl salicylate 30 % Topical CreamSY0a41ec65-bd0b-4fc6-807d-74f353341cc79

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69968-0538-2699680538021 TUBE in 1 CARTON (69968-0538-2) / 57 g in 1 TUBE1 tube2018-06-010000-00-00NoNoCurrent
69968-0538-4699680538041 TUBE in 1 CARTON (69968-0538-4) / 113 g in 1 TUBE1 tube2018-06-010000-00-00NoNoCurrent
69968-0538-5699680538052 TUBE in 1 CARTON (69968-0538-5) / 113 g in 1 TUBE2 tube2018-06-010000-00-00NoNoCurrent