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 16 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mineral Ice Extreme Dry StickMENTHOLCarlin Consumer Health LLC4f81be91-92e5-1205-e063-6394a90a6e822026-06-02WarningsExact identifier
application number: M017
Kalaya Extra Strength Pain Relief Gel with ArnicaMETHYL SALICYLATE, MENTHOL, CAMPHORAvaria Health & Beauty Corpb6a6237d-b471-4102-b5df-fc389f5f92582026-06-02WarningsExact identifier
application number: M017
Biofreeze UltraflexLIDOCAINEReckitt Benckiser LLC2655974b-a67d-9f07-e063-6294a90a54e82026-06-02WarningsExact identifier
application number: M017
Biofreeze Ultraflex PlusLIDOCAINE, MENTHOLReckitt Benckiser LLC401e1843-e9a6-fda9-e063-6294a90a30732026-06-02WarningsExact identifier
application number: M017
Pain ReliefMENTHOL SPRAYOwell Naturals Brand, LLC534c871c-da35-6135-e063-6294a90aa9f62026-06-02WarningsExact identifier
application number: M017
Charm Tex FLUORIDE GelSODIUM FLUORIDEJiangsu Gold Worldworks Household Chemicals Co., Ltd.09d47bd7-1438-4ef2-85e0-9cd5eb2f763a2026-05-31WarningsExact identifier
application number: M017
Charm Tex FLUORIDESODIUM MONOFLUOROPHOSPHATEJiangsu Gold Worldworks Household Chemicals Co., Ltd.2bddc69a-0c0f-47fc-bc98-90c2ec70dd6f2026-05-31WarningsExact identifier
application number: M017
Sting Relief Prep PadBENZOCAINENINGBO TIANBO FIRST AID PRODUCT CO., LTD.9487d15d-9116-4ff8-a004-ba0835ea091e2026-05-31WarningsExact identifier
application number: M017
Careland Kinesiology Pain Relieving TapeCAMPHOR (SYNTHETIC), MENTHOL, METHYL SALICYLATEPlanet (Anhui) Pharmaceutical Co., Ltd.35d24cfc-9d34-4fd7-9312-1673b092a3b92026-05-31WarningsExact identifier
application number: M017
Walgreens Scalp Itch ReliefHYDROCORTISONEWalgreens34952272-1f9e-c642-e063-6394a90ae2bd2026-05-29WarningsExact identifier
application number: M017
Aspercreme with Lidocaine No-Mess ApplicatorLIDOCAINE HYDROCHLORIDEChattem, Inc.8092cde7-28d0-4755-b5c0-5765934e572f2026-05-29WarningsExact identifier
application number: M017
Belladona and ArnicaMENTHOLDannso Corp./d.b.a. Essential Productsfc4e63e4-cebc-49ff-8900-7238261d0fe02026-05-28WarningsExact identifier
application number: M017
Insect Sting ReliefBENZOCAINE, ALCOHOLHubei Fanjian Medical Product Co.,Ltdf30401c1-961e-44dd-e053-2a95a90a69d62026-05-28WarningsExact identifier
application number: M017
Menthol plus Camphor Pain ReliefMENTHOL, CAMPHORVeridian Healthcare4a054949-0889-7182-e063-6394a90aff5e2026-05-28WarningsExact identifier
application number: M017
Antibacterial Lidocaine Wound GelBENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDECVS Pharmacy960bfe55-87f6-3e51-e053-2995a90a867d2026-05-27WarningsExact identifier
application number: M017
MyDerm Medical 5 Lidocaine Numbing Roll-OnLIDOCAINEInspec Solutions1d466be1-a780-462f-8dd4-87478da096aa2026-05-27WarningsExact identifier
application number: M017
myDerm Cooling Menthol Pain Relief with 50 Percent More MentholMENTHOLInspec Solutions LLC.d427d623-c2fd-7d6b-e053-2995a90abdc32026-05-27WarningsExact identifier
application number: M017
Caldyphen ClearPRAMOXINE HYDROCHLORIDE AND ZINC ACETATEAmerisource Bergend8802e56-649e-4494-86ee-7ca8841cc28b2026-05-27WarningsExact identifier
application number: M017
Equate Itch Relief GelITCH RELIEF GELWalmart, Inc7d7bb750-017e-c60e-e053-2991aa0ad6712026-05-26WarningsExact identifier
application number: M017
MyDerm Bite and StingBENZOCAINEMedline Industriesbf45c4dd-5814-4602-b96b-f82a449487632026-05-26WarningsExact 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