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 126 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Medicated Herbal Lip BalmMENTHOLEarth Mama Angel Baby LLC1cc2391e-6a7a-609c-e063-6394a90a63052024-10-01WarningsExact identifier
application number: M017
CVS Health Lidocaine Plus Pain RelievingLIDOCAINE HYDROCHLORIDE, BENZYL ALCOHOLNATURAL ESSENTIALS, INC.1adb9b74-4a01-4461-b845-f3aedcb3f8102024-10-01WarningsExact identifier
application number: M017
CircataCAPSAICINPureTek Corporationb67161d7-cc5c-e971-e053-2995a90acbe72024-10-01WarningsExact identifier
application number: M017
MenticamCAMPHOR,MENTHOL, METHYL SALICYLATEPureTek Corporationffea2e97-777f-434b-e053-6394a90a3a632024-10-01WarningsExact identifier
application number: M017
Herb Street Sore Muscle ReliefMETHYL SALICYLATEBalassa Laboratories Inc.e43943c2-d4cd-44c5-a0ff-403a8d42860f2024-10-01WarningsExact identifier
application number: M017
hydrocortisoneHYDROCORTISONEKroger Company68dab606-0385-48b7-9a7b-a2cf83d203932024-09-29WarningsExact identifier
application number: M017
kirkland signature hydrocortisone plus maximum strengthHYDROCORTISONECostco Wholesale Company481341c5-db1f-43fb-aed7-f40495a4eab82024-09-29WarningsExact identifier
application number: M017
Care One hydrocortisone maximum strengthHYDROCORTISONEAmerican Sales Company32593229-d0ac-4d6c-831a-089fc6e761522024-09-29WarningsExact identifier
application number: M017
good sense anti itchHYDROCORTISONEL. Perrigo Companyb7a896cc-1d78-45c0-a73e-aa1e117f7d3b2024-09-29WarningsExact identifier
application number: M017
Topcare HydrocortisoneHYDROCORTISONETopco Associates LLCb7362f21-f1a3-4edc-b5b6-a16680e05df32024-09-29WarningsExact identifier
application number: M017
hydrocortisoneHYDROCORTISONEH E B412ca2d1-064b-4438-aee1-fcb5cf27c7db2024-09-29WarningsExact identifier
application number: M017
Topcare AntibioticNEOMYCIN, POLYMYXIN B, PRAMOXINE HYDROCHLORIDETopco Associates LLC8c349cac-20e1-4600-9b0a-fcfe929551c52024-09-26WarningsExact identifier
application number: M017
good sense anti itchHYDROCORTISONEA-S Medication Solutions072dd455-24a5-4a44-aaef-d3e137d005a62024-09-26WarningsExact identifier
application number: M017
SYREN Intimate ReliefLIDOCAINE HYDROCHLORIDEIcon Health Science57d5a080-3583-4510-e053-2a91aa0ad5892024-09-25WarningsExact identifier
application number: M017
AOSI HEALTHCAREHYDROCORTISONENantong Health & Beyond Hygienic Products Inc.f4db90ad-dd62-44f1-9655-2614ed36581e2024-09-25WarningsExact identifier
application number: M017
AOSI HEALTHCARE BURNLIDOCAINE HYDROCHLORIDE, BENZALKONIUM CHLORIDENantong Health & Beyond Hygienic Products Inc.a28b920c-0bb8-4b5a-addd-26ea164e036e2024-09-25WarningsExact identifier
application number: M017
anti itchDIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATEKroger Company067e718a-ec0b-4895-8f9f-82d64ab4c7b42024-09-24WarningsExact identifier
application number: M017
topcare anti itchDIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATETopco Associates LLCe0fb332a-2903-41ef-b35b-7cd3a74cff992024-09-24WarningsExact identifier
application number: M017
equaline anti itchHYDROCORTISONEUnited Natural Foods, Inc. dba UNFI83cd9f60-a4c4-4dea-97a7-cd96aade9e882024-09-24WarningsExact identifier
application number: M017
good sense itch reliefDIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATEL. Perrigo Company162fe0a3-3995-4e6f-94ed-f839b2b0c80e2024-09-24WarningsExact 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