FDA.reportPublic FDA data

WHITE FLOWER ANALGESIC BALM

Product NDC
48256-0002
11-digit product format
482560002
Labeler code
48256
Product ID
48256-0002_41b65c5d-df46-b694-e063-6394a90a6d09
Type
HUMAN OTC DRUG
Nonproprietary name
CAMPHOR, MENTHOL AND METHYL SALICYLATE
Dosage form
OIL
Route
TOPICAL
Labeler
HOE HIN PAK FAH YEOW MANUFACTORY LTD
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2010-06-11
Substance
CAMPHOR (SYNTHETIC); MENTHOL; METHYL SALICYLATE
Active strength
6; 14.5; 40.02 g/100mL; g/100mL; g/100mL
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
WHITE FLOWER ANALGESIC BALM
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CAMPHOR (SYNTHETIC)6 g/100mL
MENTHOL14.5 g/100mL
METHYL SALICYLATE40.02 g/100mL

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
1053407Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
f3e3b8b5-b12b-49ac-9318-b0c358b136e9Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
48256-0002-1WHITE FLOWER ANALGESIC BALM20 mL in 1 BOTTLE, GLASSOIL209
48256-0002-2WHITE FLOWER ANALGESIC BALM10 mL in 1 BOTTLE, GLASSOIL109
48256-0002-3WHITE FLOWER ANALGESIC BALM5 mL in 1 BOTTLE, GLASSOIL59
48256-0002-4WHITE FLOWER ANALGESIC BALM2.5 mL in 1 BOTTLE, GLASSOIL2.59

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CAMPHOR (SYNTHETIC)ACTIVE INGREDIENT5TJD82A1ETWHITE FLOWER ANALGESIC BALM (CAMPHOR, MENTHOL AND METHYL SALICYLATE) OIL [HOE HIN PAK FAH YEOW MANUFACTORY LTD]4
MENTHOLACTIVE INGREDIENTL7T10EIP3AWHITE FLOWER ANALGESIC BALM (CAMPHOR, MENTHOL AND METHYL SALICYLATE) OIL [HOE HIN PAK FAH YEOW MANUFACTORY LTD]4
METHYL SALICYLATEACTIVE INGREDIENTLAV5U5022YWHITE FLOWER ANALGESIC BALM (CAMPHOR, MENTHOL AND METHYL SALICYLATE) OIL [HOE HIN PAK FAH YEOW MANUFACTORY LTD]4
CAMPHOR (SYNTHETIC)ACTIVE MOIETY5TJD82A1ETWHITE FLOWER ANALGESIC BALM (CAMPHOR, MENTHOL AND METHYL SALICYLATE) OIL [HOE HIN PAK FAH YEOW MANUFACTORY LTD]4
MENTHOLACTIVE MOIETYL7T10EIP3AWHITE FLOWER ANALGESIC BALM (CAMPHOR, MENTHOL AND METHYL SALICYLATE) OIL [HOE HIN PAK FAH YEOW MANUFACTORY LTD]4
SALICYLIC ACIDACTIVE MOIETYO414PZ4LPZWHITE FLOWER ANALGESIC BALM (CAMPHOR, MENTHOL AND METHYL SALICYLATE) OIL [HOE HIN PAK FAH YEOW MANUFACTORY LTD]4
EUCALYPTUS OILINACTIVE INGREDIENT2R04ONI662WHITE FLOWER ANALGESIC BALM (CAMPHOR, MENTHOL AND METHYL SALICYLATE) OIL [HOE HIN PAK FAH YEOW MANUFACTORY LTD]4
LAVENDER OILINACTIVE INGREDIENTZBP1YXW0H8WHITE FLOWER ANALGESIC BALM (CAMPHOR, MENTHOL AND METHYL SALICYLATE) OIL [HOE HIN PAK FAH YEOW MANUFACTORY LTD]4
PEPPERMINT OILINACTIVE INGREDIENTAV092KU4JHWHITE FLOWER ANALGESIC BALM (CAMPHOR, MENTHOL AND METHYL SALICYLATE) OIL [HOE HIN PAK FAH YEOW MANUFACTORY LTD]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
48256-0002WHITE FLOWER ANALGESIC BALM (CAMPHOR, MENTHOL AND METHYL SALICYLATE) OIL [HOE HIN PAK FAH YEOW MANUFACTORY LTD]8Current NDC, Legacy NDC, 4 package rows20231003_f3e3b8b5-b12b-49ac-9318-b0c358b136e9.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 104 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Healing Hand Cream 2000mgMENTHOLCarolina Cannabis Creations LLC01f8795b-9f95-c793-e063-6394a90a83302025-01-15WarningsExact identifier
application number: M017
CBD Clinic Deep-Rub Pain Relief - Level 5CAMPHOR, MENTHOLABACUS HEALTH PRODUCTS, INC.31e2e5cd-d33e-f058-e063-6394a90af7d22025-01-14WarningsExact identifier
application number: M017
Meijer Odor Free Analgesic Pain Relieving Topical AnalgesicLIDOCAINE HYDROCHLORIDEMeijer Distribution, Inc6288efea-f636-4eea-bb9f-78aa2f9af54a2025-01-14WarningsExact identifier
application number: M017
IKONIK TONIKLIDOCAINE HYDROCHLORIDEIKONIK CARE, LLC122fdfe8-b5fa-46d1-9fd9-3df9887ed3202025-01-14WarningsExact identifier
application number: M017
elp essential MANTECA DE UBREMETHYL SALICYLATE, CAMPHORMiramar Cosmetics, Inc DBA Miramar Labc3964dfe-17fe-4d89-a4c4-cf500f9822592025-01-13WarningsExact identifier
application number: M017
MethyltenMETHYL SALICYLATE 10%Puretek Corporation28f4093f-803f-0e70-e063-6294a90a98a42025-01-13WarningsExact identifier
application number: M017
Refill Bundle 7 Large OfficeBENZALKONIUM CHLORIDECMC Group, Inc.6620a8f3-098d-d045-e053-2a91aa0a0d942025-01-13WarningsExact identifier
application number: M017
Jakwork Numbing CreamNUMBING CREAMGuangzhou Zanming Trading Co., Ltd.2ba1de83-494a-6c54-e063-6294a90a9b2d2025-01-13WarningsExact identifier
application number: M017
Arthritis HotMENTHOL AND METHYL SALICYLATEChattem, Inc.cc57b9b6-8ba5-4ff3-a5df-97d8f5b1bebd2025-01-13WarningsExact identifier
application number: M017
Re-Lieved Lidocaine PatchLIDOCAINE PATCH 4%Transfer Technology00b40dda-53ad-0458-e063-6394a90aa8352025-01-11WarningsExact identifier
application number: M017
Re-Lieved Lidocaine PatchLIDOCAINE PATCH 4%Transfer Technology00b47eb7-6b43-d9e2-e063-6294a90a9a382025-01-11WarningsExact identifier
application number: M017
Re-Lieved 4% Lidocaine Fabric TapeLIDOCAINE 4% FABRIC TAPETransfer Technologye9a894b0-54f2-707e-e053-2a95a90a0f0d2025-01-11WarningsExact identifier
application number: M017
Re-Lieved 3 in 1 PatchMENTHOL, CAMPHOR, METHYL SALICYLATE PATCHTransfer Technologye9ab9a03-b9e3-7317-e053-2995a90a99502025-01-11WarningsExact identifier
application number: M017
ASTRAPHARM CHILLI BRANDCAPSAICINDersan Pharmaceutical Co., Ltdb4c2d4fd-7d5d-4156-ac27-e72ebc9671ec2025-01-10WarningsExact identifier
application number: M017
LABOFLEX Lidocaine Pain Relieving PatchLIDOCAINE 4%Laboflex, Inc.31995f31-c272-afdb-e063-6294a90af3f92025-01-10WarningsExact identifier
application number: M017
Anti-Itch CreamDIPHENHYDRAMINE HYDROCHLORIDE 2%, ZINC ACETATE 0.1%Chain Drug Marketing Association Inc.2b48cb2f-e6bf-f9de-e063-6394a90a42d42025-01-09WarningsExact identifier
application number: M017
PAIN-XMENTHOLOL PHARMA TECH,LLCb22bb19a-14e5-3d32-e053-2a95a90ae5202025-01-09WarningsExact identifier
application number: M017
MUSCLE RUBMENTHOLOL PHARMA TECH,LLCb22c7999-52d5-25c3-e053-2a95a90a01f52025-01-09WarningsExact identifier
application number: M017
Biofreeze Professional Colorless Roll-OnMENTHOL, UNSPECIFIED FORMA-S Medication Solutionsce392c4f-cc43-484d-9c49-18fa25e4e5e92025-01-09WarningsExact identifier
application number: M017
NEW TEROCINMETHYL SALICYLATE, CAPSAICIN, AND MENTHOLA-S Medication Solutions43e5eb27-5541-4b7b-80de-55a79a4dce552025-01-09WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1053407camphor 6 % / menthol 15 % / methyl salicylate 40 % Topical OilPSNf3e3b8b5-b12b-49ac-9318-b0c358b136e99
1053407camphor 60 MG/ML / menthol 150 MG/ML / methyl salicylate 400 MG/ML Topical OilSCDf3e3b8b5-b12b-49ac-9318-b0c358b136e99
1053407camphor 6 % / menthol 15 % / methyl salicylate 40 % Topical OilSYf3e3b8b5-b12b-49ac-9318-b0c358b136e99

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
48256-0002-14825600020120 mL in 1 BOTTLE, GLASS (48256-0002-1) 20 ml2018-10-010000-00-00NoNoCurrent
48256-0002-24825600020210 mL in 1 BOTTLE, GLASS (48256-0002-2) 10 ml2018-10-010000-00-00NoNoCurrent
48256-0002-3482560002035 mL in 1 BOTTLE, GLASS (48256-0002-3) 5 ml2018-10-010000-00-00NoNoCurrent
48256-0002-4482560002042.5 mL in 1 BOTTLE, GLASS (48256-0002-4) 2.5 ml2018-10-010000-00-00NoNoCurrent