Boroleum

Product NDC
69618-052
11-digit product format
696180052
Labeler code
69618
Product ID
69618-052_2bc8028b-eeba-902f-e063-6394a90a382b
Type
HUMAN OTC DRUG
Nonproprietary name
Camphor, Menthol, White Petrolatum
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Reliable 1 Laboratories
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-04-16
Substance
WHITE PETROLATUM; CAMPHOR (SYNTHETIC); MENTHOL
Active strength
97.92; 1; .54 g/100g; g/100g; g/100g
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
Boroleum
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
WHITE PETROLATUM97.92 g/100g
CAMPHOR (SYNTHETIC)1 g/100g
MENTHOL.54 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
B6E5W8RQJ4Internal UNII lookup
5TJD82A1ETInternal UNII lookup
L7T10EIP3AInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1050087Internal RxNorm lookup
1050091Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
846568af-0fdd-a80e-e053-2a91aa0a9c9eAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69618-052-77Boroleum17 g in 1 TUBEOINTMENT174
69618-052-77Boroleum1 in 1 CARTONOINTMENT14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69618-052-77GM - Gram69618-052af5f38df-4335-46d0-99e9-2076da8cf62112022-09-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69618-052BOROLEUM (CAMPHOR, MENTHOL, WHITE PETROLATUM) OINTMENT [RELIABLE 1 LABORATORIES]4Current NDC, Legacy NDC, 2 package rows20250117_846568af-0fdd-a80e-e053-2a91aa0a9c9e.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
1050091BOROLEUM 1 % / 0.54 % / 97.92 % Topical OintmentPSN846568af-0fdd-a80e-e053-2a91aa0a9c9e4
1050087camphor 1 % / menthol 0.54 % / petrolatum 97.92 % Topical OintmentPSN846568af-0fdd-a80e-e053-2a91aa0a9c9e4
1050091camphor 0.01 MG/MG / menthol 0.0054 MG/MG / petrolatum 0.98 MG/MG Topical Ointment [Boroleum]SBD846568af-0fdd-a80e-e053-2a91aa0a9c9e4
1050087camphor 0.01 MG/MG / menthol 0.0054 MG/MG / petrolatum 0.98 MG/MG Topical OintmentSCD846568af-0fdd-a80e-e053-2a91aa0a9c9e4
1050091Boroleum (camphor 1 % / menthol 0.54 % / petrolatum, white 97.92 % ) Topical OintmentSY846568af-0fdd-a80e-e053-2a91aa0a9c9e4
1050087camphor 1 % / menthol 0.54 % / petrolatum, white 97.92 % Topical OintmentSY846568af-0fdd-a80e-e053-2a91aa0a9c9e4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69618-052-77696180052771 TUBE in 1 CARTON (69618-052-77) / 17 g in 1 TUBE1 tube2019-04-160000-00-00NoNoCurrent