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 15 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lidocaine and MentholLIDOCAINE AND MENTHOLAdvanced Rx of Tennessee, LLC44840250-2112-6ef4-e063-6394a90acdcc2026-06-12WarningsExact identifier
application number: M017
DRAWYUM Pain Relief Gel-PatchLIDOCAINE 4% PAIN RELIEF GEL-PATCHJiangxi Yudexi Pharmaceutical Co., LTD497e6e18-ba46-0001-e063-6294a90af0262026-06-12WarningsExact identifier
application number: M017
NATUHEAL JOINT BACK PAIN RELIEFARNICA MONTANA HPUS 7% JOINT BACK PAIN RELIEFJiangxi Yudexi Pharmaceutical Co., LTD4c923afa-4d1e-0776-e063-6294a90a2f542026-06-12WarningsExact identifier
application number: M017
Hydrocortisone with AloeHYDROCORTISONE CREAM 1%Aldermed Inc.4a7b532e-b292-b595-e063-6394a90acc9c2026-06-12WarningsExact identifier
application number: M017
MG PLUS MENTHOLMENTHOLRENU LABORATORIES, LLC53737365-b985-3800-e063-6294a90a37f22026-06-11WarningsExact identifier
application number: M017
CeraVe Developed with Dermatologists Itch Relief MoisturizingPRAMOXINE HYDROCHLORIDEL'Oreal USA Products Inc7c78d980-fc94-498c-aec5-464c0c76c8f42026-06-11WarningsExact identifier
application number: M017
ANIXIKE NumbingLIDOCAINE4% NUMBINGJiangxi Yudexi Pharmaceutical Co., LTD4a47f1ed-d8cf-3b0b-e063-6394a90a932a2026-06-11WarningsExact identifier
application number: M017
Anti-Itch Soothing Wipes 1 Pramoxine HydrochloridePRAMOXINE HYDROCHLORIDEThe Honey Pot Company LLC81ab7fa7-d9b0-49dc-9782-02f37e588c5e2026-06-10WarningsExact identifier
application number: M017
HealthWise Pain Relief Cream with LidocaineLIDOCAINE HYDROCHLORIDEVeridian Healthcareef176d33-10b9-ddb2-e053-2995a90a76e32026-06-10WarningsExact identifier
application number: M017
Warm Patch Tong Gu Huo Luo GaoPAIN PATCHSheng Chang Pharmaceutical Co, Ltd. Zhongli Factory6906c4a0-1557-45e3-b915-80e4dd652ee72026-06-10WarningsExact identifier
application number: M017
LidoMedixLIDOCAINE, MENTHOL, CAMPHORAbsolute Therapeutics, LLC53d504ef-eea3-6a47-e063-6394a90a1f652026-06-09WarningsExact identifier
application number: M017
good sense anti itchHYDROCORTISONEPreferred Pharmaceuticals Inc.e51047da-8e17-4dd7-be3c-54820a7485f22026-06-09WarningsExact identifier
application number: M017
Terramed Just Think Comfort GynoCare BV Guard Intimate WashPRAMOXINE HYDROCHLORIDERida LLC09964550-049c-4c3b-817d-37e660c2e45c2026-06-08WarningsExact identifier
application number: M017
Quality Choice Lidocaine Pain Relief PatchLIDOCAINEQuality Choice (CHAIN DRUG MARKETING ASSOCIATION)526abe69-4bbc-6e73-e063-6394a90ad25d2026-06-08WarningsExact identifier
application number: M017
Dcsily Numbing CreamLIDOCAINEShenzhen Xinxin Yunhai Technology Co., Ltd.53cab09c-6d5d-471e-e063-6294a90aa9772026-06-08WarningsExact identifier
application number: M017
Easment 0.1% Capsaicin cream for sensitive skinCAPSAICIN 0.1%Easment LLC537e0106-9e1c-66b8-e063-6294a90ac5382026-06-05WarningsExact identifier
application number: M017
Maximum Strength Pain ReliefMENTHOL CREAMOWELL NATURALS LLC5388f2c5-8cfd-a601-e063-6294a90a2e5f2026-06-04WarningsExact identifier
application number: M017
MG PLUS ROLL ONMENTHOL ROLL ONRENU LABORATORIES, LLC535dc42f-38c7-2afc-e063-6294a90ae23d2026-06-03WarningsExact identifier
application number: M017
OP First Aid Series Insect Sting Relief PadBENZOCAINE, ISOPROPYL ALCOHOLYiwu Ori-Power Medtech Co.,Ltd.b43af183-834a-0f64-e053-2995a90a32182026-06-03WarningsExact identifier
application number: M017
PURE PRIMAL DELAYLIDOCAINE HCLProdigy Media Inc1ddab664-7c44-452f-854f-e386cd69505e2026-06-03WarningsExact 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