FDA.reportPublic FDA data

WHITE FLOWER ANALGESIC BALM FLORAL SCENTED

Product NDC
48256-0011
11-digit product format
482560011
Labeler code
48256
Product ID
48256-0011_06c8a808-955c-6bd6-e063-6294a90a40fd
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
2010-07-30
Substance
CAMPHOR (SYNTHETIC); MENTHOL; METHYL SALICYLATE
Active strength
5.4; 13; 35.8 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 FLORAL SCENTED
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CAMPHOR (SYNTHETIC)5.4 g/100mL
MENTHOL13 g/100mL
METHYL SALICYLATE35.8 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
1053359Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
4e9cb5aa-b0aa-4a5c-b561-cc38437758d8Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
48256-0011-1WHITE FLOWER ANALGESIC BALM FLORAL SCENTED10 mL in 1 BOTTLE, GLASSOIL109
48256-0011-2WHITE FLOWER ANALGESIC BALM FLORAL SCENTED5 mL in 1 BOTTLE, GLASSOIL59

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CAMPHOR (SYNTHETIC)ACTIVE INGREDIENT5TJD82A1ETWHITE FLOWER ANALGESIC BALM FLORAL SCENTED (CAMPHOR, MENTHOL AND METHYL SALICYLATE) OIL [HOE HIN PAK FAH YEOW MANUFACTORY LTD]4
MENTHOLACTIVE INGREDIENTL7T10EIP3AWHITE FLOWER ANALGESIC BALM FLORAL SCENTED (CAMPHOR, MENTHOL AND METHYL SALICYLATE) OIL [HOE HIN PAK FAH YEOW MANUFACTORY LTD]4
METHYL SALICYLATEACTIVE INGREDIENTLAV5U5022YWHITE FLOWER ANALGESIC BALM FLORAL SCENTED (CAMPHOR, MENTHOL AND METHYL SALICYLATE) OIL [HOE HIN PAK FAH YEOW MANUFACTORY LTD]4
CAMPHOR (SYNTHETIC)ACTIVE MOIETY5TJD82A1ETWHITE FLOWER ANALGESIC BALM FLORAL SCENTED (CAMPHOR, MENTHOL AND METHYL SALICYLATE) OIL [HOE HIN PAK FAH YEOW MANUFACTORY LTD]4
MENTHOLACTIVE MOIETYL7T10EIP3AWHITE FLOWER ANALGESIC BALM FLORAL SCENTED (CAMPHOR, MENTHOL AND METHYL SALICYLATE) OIL [HOE HIN PAK FAH YEOW MANUFACTORY LTD]4
SALICYLIC ACIDACTIVE MOIETYO414PZ4LPZWHITE FLOWER ANALGESIC BALM FLORAL SCENTED (CAMPHOR, MENTHOL AND METHYL SALICYLATE) OIL [HOE HIN PAK FAH YEOW MANUFACTORY LTD]4
EUCALYPTUS OILINACTIVE INGREDIENT2R04ONI662WHITE FLOWER ANALGESIC BALM FLORAL SCENTED (CAMPHOR, MENTHOL AND METHYL SALICYLATE) OIL [HOE HIN PAK FAH YEOW MANUFACTORY LTD]4
LAVENDER OILINACTIVE INGREDIENTZBP1YXW0H8WHITE FLOWER ANALGESIC BALM FLORAL SCENTED (CAMPHOR, MENTHOL AND METHYL SALICYLATE) OIL [HOE HIN PAK FAH YEOW MANUFACTORY LTD]4
PEPPERMINT OILINACTIVE INGREDIENTAV092KU4JHWHITE FLOWER ANALGESIC BALM FLORAL SCENTED (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
48256-0011WHITE FLOWER ANALGESIC BALM FLORAL SCENTED (CAMPHOR, MENTHOL AND METHYL SALICYLATE) OIL [HOE HIN PAK FAH YEOW MANUFACTORY LTD]9Current NDC, Legacy NDC, 2 package rows20231003_4e9cb5aa-b0aa-4a5c-b561-cc38437758d8.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 43 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SarnaPRAMOXINE HYDROCHLORIDECrown Laboratories19b0ce1b-e147-01a1-e063-6394a90af8082026-01-12WarningsExact identifier
application number: M017
SarnaPRAMOXINE HYDROCHLORIDE, MENTHOLCrown Laboratories, Inc19c41e75-a654-90cf-e063-6394a90a7e972026-01-12WarningsExact identifier
application number: M017
Itch ReliefDIPHENHYDRAMINE HCL, ZINC ACETATEHY-VEE, INC48350b54-8d9a-48c4-e063-6394a90ac0402026-01-12WarningsExact identifier
application number: M017
LidoPlus Pain ReliefLIDOCAINE HYDROCHLORIDECentura Pharmaceuticals, Inc07bacc6c-60a6-4297-8663-904a22bdc0402026-01-12WarningsExact identifier
application number: M017
BlueStop MaxEXTERNAL ANALGESICClavel Corporationf1efb51c-5217-4cb2-e053-2a95a90a7f952026-01-12WarningsExact identifier
application number: M017
BlueStop MaxEXTERNAL ANALGESICClavel Corporationf2277e27-868b-57ef-e053-2a95a90abf282026-01-12WarningsExact identifier
application number: M017
BLT 3TETRACAINECENTURA PHARMACEUTICALS INC401a0d22-1181-02ac-e054-00144ff88e882026-01-12WarningsExact identifier
application number: M017
Sting Relief Prep PadBENZOCAINENINGBO TIANBO FIRST AID PRODUCT CO., LTD.0c901f64-6890-45c0-9ca7-ee9de87903c42026-01-12WarningsExact identifier
application number: M017
Goodsense Oral Pain ReliefBENZOCAINEGeiss, Destin and Dunn, Inc.eb461b70-d10f-4e11-8374-e43713f3504d2026-01-12WarningsExact identifier
application number: M017
Extra Strength BalmCAPSICUM AND MENTHOLSaje Natural Business Incf516e416-446b-8f21-e053-2a95a90afd882026-01-12WarningsExact identifier
application number: M017
Pain ReleaseMENTHOLSaje Natural Business Inc.3df0e56a-7651-42dc-8ed8-f68836a63c612026-01-12WarningsExact identifier
application number: M017
Trauma LessMENTHOLSaje Natural Business Inc.650cba4c-6aba-48c3-9c41-841f199055482026-01-12WarningsExact identifier
application number: M017
MamisanLIDOCAINE HYDROCHLORIDE, MENTHOLMiramar Cosmetics, Inc DBA Miramar Lab4402e900-c6e9-4f32-8cc4-c84014384a9f2026-01-12WarningsExact identifier
application number: M017
Curist Lidocaine PatchLIDOCAINE 4% PATCHLittle Pharma, Inc.1a8fe44e-7a21-c2ab-e063-6394a90a61002026-01-11WarningsExact identifier
application number: M017
DG Health Pain RelievingLIDOCAINE HCLDOLGENCORP, LLC923aeb4c-049f-4ecc-a77e-9ffa0e236d4e2026-01-11WarningsExact identifier
application number: M017
Campho-Phenique AntisepticCAMPHOR (SYNTHETIC) AND PHENOLFoundation Consumer Healthcare46b84e0b-78a9-4cde-9f90-e165b54191622026-01-09WarningsExact identifier
application number: M017
MyDerm Pro Freeze Cooling Menthol Pain Relief Roll-OnMENTHOLInspec Solutions12ff9b9a-73e5-ce31-e063-6294a90aeaf82026-01-09WarningsExact identifier
application number: M017
Carmex Classic Lip Balm MedicatedCAMPHOR (SYNTHETIC), WHITE PETROLATUMCarma Laboratories, Inc.bb0278c9-eaff-d435-e053-2995a90a202a2026-01-09WarningsExact identifier
application number: M017
Lidocaine HCILIDOCAINE HCITrifluent Pharma, LLC47f7f06b-720e-eeec-e063-6294a90ae8232026-01-09WarningsExact identifier
application number: M017
LidocaineLIDOCAINEBellus Medical, LLC60cb89f6-e326-0773-e053-2a91aa0a33dd2026-01-09WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1053359camphor 5.4 % / menthol 13.1 % / methyl salicylate 36 % Topical OilPSN4e9cb5aa-b0aa-4a5c-b561-cc38437758d89
1053359camphor 54 MG/ML / menthol 131 MG/ML / methyl salicylate 360 MG/ML Topical OilSCD4e9cb5aa-b0aa-4a5c-b561-cc38437758d89
1053359camphor 5.4 % / menthol 13.1 % / methyl salicylate 36 % Topical OilSY4e9cb5aa-b0aa-4a5c-b561-cc38437758d89

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
48256-0011-14825600110110 mL in 1 BOTTLE, GLASS (48256-0011-1) 10 ml2010-07-300000-00-00NoNoCurrent
48256-0011-2482560011025 mL in 1 BOTTLE, GLASS (48256-0011-2) 5 ml2010-07-300000-00-00NoNoCurrent