FDA.reportPublic FDA data

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 90 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Re-Lieved Lidocaine PatchLIDOCAINE PATCH 4%Transfer Technology37ef02d4-2ff5-cb23-e063-6294a90a68af2025-06-19WarningsExact identifier
application number: M017
Post-Treatment Repair CreamHYDROCORTISONEVi Medical Products Inc.ab8885a9-0778-28ff-e053-2995a90a2e122025-06-19WarningsExact identifier
application number: M017
MyDermLIDOCAINEInspec Solutions LLC.82d075d1-c92e-2097-e053-2991aa0ab1312025-06-18WarningsExact identifier
application number: M017
Walgreens Extra Small LidocaineLIDOCAINEWalgreen Co.dc838e47-d234-4ba5-9449-f645e99be9232025-06-18WarningsExact identifier
application number: M017
CLn Body MoisturizerCOLLOIDAL OAT MOISTURIZERTopMD Skin Care, Inc.2de3d68d-a540-d456-e063-6394a90a4b572025-06-18WarningsExact identifier
application number: M017
Aloe UP SPF 30 MineralZINC OXIDE, TITANIUM DIOXIDEAloe Care International, LLC35967b33-bdfb-ee3c-e063-6294a90a75f62025-06-18WarningsExact identifier
application number: M017
Aloe Up SPF 50 MineralZINC OXIDE, TITANIUM DIOXIDEAloe Care International, LLC35b9dcfa-05f3-3d7b-e063-6394a90a18f12025-06-18WarningsExact identifier
application number: M017
Aloe Up SPF 50 MineralZINC OXIDEAloe International, LLC35bc3621-f4e4-42d3-e063-6394a90a7aad2025-06-18WarningsExact identifier
application number: M017
Aloe Up SPF 50 Kids MineralZINC OXIDE, TITANIUM DIOXIDEAloe Care International, LLC35cd16b0-bd81-8f68-e063-6294a90a3d8c2025-06-18WarningsExact identifier
application number: M017
Aloe Up SPF 50 Kids MineralZINC OXIDEAloe International, LLC35cd5542-947d-a042-e063-6394a90a13f82025-06-18WarningsExact identifier
application number: M017
Relieve Your PainMENTHOLProximity Capital Partners LLC dba Asutrac12369dd-8305-edaf-e053-2995a90a0d3d2025-06-18WarningsExact identifier
application number: M017
Melt Pain AwayCAPSAICINProximity Capital Partners LLC dba Asutraa95a11d7-a2ae-6654-e053-2a95a90a802c2025-06-18WarningsExact identifier
application number: M017
Recovery Roll-OnMENTHOL, CAMPHORPROXIMITY CAPITAL PARTNERS LLC DBA ASUTRAebc9630f-6d8b-e4f0-e053-2995a90a0b492025-06-18WarningsExact identifier
application number: M017
ProCure Hydrocortisone 1%HYDROCORTISONETwin Med LLC37cdfabc-1fdb-246a-e063-6394a90a008a2025-06-17WarningsExact identifier
application number: M017
ProCure Hydrocortisone 1%HYDROCORTISONETwin Med LLC37ce6c35-b211-43de-e063-6294a90ab7732025-06-17WarningsExact identifier
application number: M017
Hydrocortisone with AloeHYDROCORTISONE CREAM 1%Sun Pharmaceutical Industries, Inc.312ddc8d-100e-cfac-e063-6294a90acd092025-06-16WarningsExact identifier
application number: M017
Curist 5% LidocaineLIDOCAINE 5%Little Pharma, Inc.f20241a2-c5b1-f124-e053-2995a90a891b2025-06-16WarningsExact identifier
application number: M017
Toast Screamin MentholMENTHOLIDEAZ, LLC37b48b1a-ef3d-afdc-e063-6294a90a66102025-06-16WarningsExact identifier
application number: M017
Toast Freezin ColdMENTHOL, METHYL SALICYLATEIDEAZ, LLC37b4d363-0099-8cd3-e063-6394a90a18d62025-06-16WarningsExact identifier
application number: M017
Earths Care Anti-ItchCAMPHOR (NATURAL) AND MENTHOL, UNSPECIFIED FORMDLC Laboratories, Inc.ba65f58a-d590-498a-b8e7-a3d78935d8802025-06-13WarningsExact 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