FDA.reportPublic FDA data

PO SUM ON HEALING BALM

Product NDC
54155-053
11-digit product format
541550053
Labeler code
54155
Product ID
54155-053_5d2fca8b-d9c2-5405-e063-6394a90a78c5
Type
HUMAN OTC DRUG
Nonproprietary name
MENTHOL
Dosage form
OINTMENT
Route
TOPICAL
Labeler
PO SUM ON MEDICINE FACTORY LIMITED
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-08-27
Marketing end
2030-09-02
Substance
MENTHOL
Active strength
13 g/100g
NDC exclude flag
No
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
PO SUM ON HEALING BALM

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL13 g/100g

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54155-053-01PO SUM ON HEALING BALM1 in 1 PACKETOINTMENT14
54155-053-01PO SUM ON HEALING BALM3.5 g in 1 JAROINTMENT3.54
54155-053-02PO SUM ON HEALING BALM18 g in 1 JAROINTMENT184
54155-053-02PO SUM ON HEALING BALM1 in 1 BOXOINTMENT14
54155-053-03PO SUM ON HEALING BALM10 g in 1 JAROINTMENT104
54155-053-03PO SUM ON HEALING BALM1 in 1 BOXOINTMENT14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54155-053PO SUM ON HEALING BALM (MENTHOL) OINTMENT [PO SUM ON MEDICINE FACTORY LIMITED]3Current NDC, Legacy NDC, 6 package rows20241127_0c89bfec-48b9-4d48-9e03-f9324447de0c.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 150 of 151 · 3,010 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
XtraCare Ice Cold Topical Analgesic GelMENTHOLRejoice Internationald38f3099-d940-44d8-aa7f-404157c5e0e32023-10-24WarningsExact identifier
application number: M017
Family WellnessDIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATEZhejiang Jingwei Pharmaceutical Co., Ltd.fefbe351-1cd9-4a2f-a43d-51e2c4eb180b2023-10-24WarningsExact identifier
application number: M017
TheraPlus PlusMENTHOLZhejiang Jingwei Pharmaceutical Co., Ltd.d4119f84-eb60-4134-b58e-de13d96011992023-10-24WarningsExact identifier
application number: M017
Family WellnessHYDROCORTISONEZhejiang Jingwei Pharmaceutical Co., Ltd.cddc9c4a-7c58-4225-921a-05d6afb491782023-10-24WarningsExact identifier
application number: M017
NUMOTIZINEMENTHOLHobart Laboratories, Inc.9a29ad1b-4ba3-403f-90c9-ee7582fe45352023-10-20WarningsExact identifier
application number: M017
Numfast Tetracaine GreenTETRACAINEUnit Dose, Ltd.77d9e6ea-1cd3-4447-ba74-01cd7143e27c2023-10-19WarningsExact identifier
application number: M017
LiprotekPETROLATUM, LIDOCAINEUnit Dose, Ltd.051cfa27-bd7c-4f8c-b3e6-03ee0b7a3aa52023-10-19WarningsExact identifier
application number: M017
GENUINE FIRST AID Antiseptic Pain RelievingBENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDENantong Health & Beyond Hygienic Products Inc.bc7c6739-6068-4694-adc9-0c0c5c347df42023-10-19WarningsExact identifier
application number: M017
CVS Itch relief moisturizingPRAMOXINE HCL 1%CVS Healthf3a753fc-f448-6bba-e053-2a95a90a8e1b2023-10-18WarningsExact identifier
application number: M017
ZylotrolLIDOCAINE HCL 4%, MENTHOL 1%Asclemed USA, Inc.e13984ea-73a9-2894-e053-2995a90a8ed62023-10-16WarningsExact identifier
application number: M017
EXOTEN-CMETHYL SALICYLATE, MENTHOL, CAPSAICINAsclemed USA, Inc.76ed37e0-64b5-4abe-a03c-3dc7084a39192023-10-16WarningsExact identifier
application number: M017
Calypxo Pain ReliefMETHYL SALICYLATE, MENTHOLAsclemed USA, Incbd9d0bc0-5705-4c73-bcd6-f6cdb68e05b62023-10-16WarningsExact identifier
application number: M017
Calypxo HP Pain ReliefMETHYL SALICYLATE, MENTHOLAsclemed USA, Inc89a8c267-bd92-4d0d-8e50-c52224aff9cd2023-10-16WarningsExact identifier
application number: M017
ZylotrolLIDOCAINE HCL 4%, MENTHOL 1%Whitestone Products LLC0e32e9c0-ff5b-4e88-89b1-f5903cd982092023-10-16WarningsExact identifier
application number: M017
CapsadynCAPSAICINChorda Pharma, Inc07731045-0d2b-76b7-e063-6294a90af9212023-10-11WarningsExact identifier
application number: M017
WHITE FLOWER STRAIN RELIEFCAMPHOR, MENTHOL AND METHYL SALICYLATEHOE HIN PAK FAH YEOW MANUFACTORY LTD65282267-de63-453a-a686-f8752c71b9ef2023-10-02WarningsExact identifier
application number: M017
WHITE FLOWER ANALGESIC BALM FLORAL SCENTEDCAMPHOR, MENTHOL AND METHYL SALICYLATEHOE HIN PAK FAH YEOW MANUFACTORY LTD4e9cb5aa-b0aa-4a5c-b561-cc38437758d82023-10-02WarningsExact identifier
application number: M017
NATUREANCE BODY BALMCAMPHOREROS GLOBAL CORP05b84fd2-8d8f-9249-e063-6294a90ae29f2023-09-19WarningsExact identifier
application number: M017
U ICE COLDMENTHOLUNIVERSAL DISTRIBUTION CENTER LLC752ef0cd-f12a-3b9e-e053-2991aa0abeb12023-09-01WarningsExact identifier
application number: M017
Family Wellness Pain Relief with LidocainePAIN RELIEF WITH LIDOCAINEFAMILY DOLLAR (Family Wellness)3a18119f-6c75-4cea-a990-97cb8a9589d42023-08-29WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1923499menthol 13 % Topical OintmentPSN0c89bfec-48b9-4d48-9e03-f9324447de0c4
1923499menthol 0.13 MG/MG Topical OintmentSCD0c89bfec-48b9-4d48-9e03-f9324447de0c4
1923499menthol 13 % Topical OintmentSY0c89bfec-48b9-4d48-9e03-f9324447de0c4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
54155-053-01541550053011 JAR in 1 PACKET (54155-053-01) / 3.5 g in 1 JAR1 jar2026-08-272030-09-02NoNoCurrent
54155-053-02541550053021 JAR in 1 BOX (54155-053-02) / 18 g in 1 JAR1 jar2026-08-272030-09-02NoNoCurrent
54155-053-03541550053031 JAR in 1 BOX (54155-053-03) / 10 g in 1 JAR1 jar2026-08-272030-09-02NoNoCurrent