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 129 of 151 · 3,020 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Fruit of the Earth Aloe Vera Cool BlueLIDOCAINE HYDROCHLORIDEFruit of the Earth, Inc.1d65bc34-2bc2-4f52-a9b3-1cb08324eb792024-07-19WarningsExact identifier
application number: M017
Ultra BalmMENTHOL AND METHYL SALICYLATELing Nam Medicine Factory (H.K.) Ltd.de997baf-aa04-474e-b912-3fc67e720d0b2024-07-19WarningsExact identifier
application number: M017
Ling Nam Hak Kwai OilTURPENTINE OILLing Nam Medicine Factory (H.K.) Ltd.3f16cce3-366f-41f3-8829-6de4082a8c192024-07-19WarningsExact identifier
application number: M017
Koong Yick Hak Kwai OilTURPENTINE OILLing Nam Medicine Factory (H.K.) Ltd.bc33e185-3b42-98b5-e053-2995a90a63082024-07-18WarningsExact identifier
application number: M017
Koong Yick Hung FaMETHYL SALICYLATELing Nam Medicine Factory (H.K.) Ltd.9c8a121d-6da2-4435-a2d7-a0b71d10740d2024-07-18WarningsExact identifier
application number: M017
Ling Nam Hung FarMETHYL SALICYLATELing Nam Medicine Factory (H.K.) Ltd.b6916b6e-b7eb-1eb7-e053-2995a90ae6fb2024-07-18WarningsExact identifier
application number: M017
itch reliefDIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATEBionpharma Inc.178ed513-4f22-8f11-e063-6294a90a109b2024-07-16WarningsExact identifier
application number: M017
POWERECT Benzocaine Male Delay GelBENZOCAINESKINS SEXUAL HEALTH LIMITED2fafe1f2-a31e-4b2a-bc51-81e16b319c3a2024-07-16WarningsExact identifier
application number: M017
SKINS DELAY Climax Control Benzocaine GelBENZOCAINESKINS SEXUAL HEALTH LIMITED53730576-2609-4f28-8bfa-a1ceea698b832024-07-16WarningsExact identifier
application number: M017
TIDL PAIN RELIEF CRYO THERAPY Unscented formula Spray.PAIN RELIEF CRYO THERAPY UNSCENTED FORMULA SPRAYShenzhen Sam Technology Co., Ltd.1d1a0346-3b00-4803-e063-6294a90aec6d2024-07-13WarningsExact identifier
application number: M017
Tidl Pain Relief Evening Therapy Spray.PAIN RELIEF EVENING THERAPY SPRAYShenzhen Sam Technology Co., Ltd.1d1a2f4a-7b25-e595-e063-6394a90a00d52024-07-13WarningsExact identifier
application number: M017
TIDL PAIN RELIEF HEAT THERAPY ROLL-ONPAIN RELIEF HEAT THERAPY ROLL-ONShenzhen Sam Technology Co., Ltd.1d0b7b8f-9e5d-00f7-e063-6394a90af87c2024-07-12WarningsExact identifier
application number: M017
TIDL PAIN RELIEF CRYO THERAPY original formula Spray.PAIN RELIEF CRYO THERAPY ORIGINAL FORMULA SPRAYShenzhen Sam Technology Co., Ltd.1d0b94ec-f956-dff2-e063-6294a90aca4a2024-07-12WarningsExact identifier
application number: M017
TIDL PAIN RELIEF CRYO THERAPY MAX Strength Spray.PAIN RELIEF CRYO THERAPY MAX STRENGTH SPRAYShenzhen Sam Technology Co., Ltd.1d0bf4f9-6b02-6cec-e063-6294a90a36c72024-07-12WarningsExact identifier
application number: M017
Burn ReliefLIDOCAINE HCI 2.0%Trifecta Pharmaceuticals USA, LLC.e5e524cd-bb22-715f-e053-2995a90ab5d32024-07-12WarningsExact identifier
application number: M017
Ralli Rapid Pain ReliefMENTHOLTroy Manufacturing, Inc.1d10e3ca-dc93-8e1a-e063-6394a90a47c02024-07-12WarningsExact identifier
application number: M017
TIDL PAIN RELIEF HEAT THERAPY Spray.PAIN RELIEF HEAT THERAPY SPRAYShenzhen Sam Technology Co., Ltd.1d199826-1b27-b6e7-e063-6394a90a69ad2024-07-12WarningsExact identifier
application number: M017
Tidl Pain Relief Morning Therapy Spray.PAIN RELIEF MORNING THERAPY SPRAYShenzhen Sam Technology Co., Ltd.1d19d070-3818-73de-e063-6394a90a89582024-07-12WarningsExact identifier
application number: M017
Hydrocortisone with aloeHYDROCORTISONE WITH ALOE ANTI ITCHNeilMed Pharmaceuticals Inc.032b9f58-5f64-04dd-e063-6294a90a6bb92024-07-10WarningsExact identifier
application number: M017
Octagon Pain ReliefMENTHOL, UNSPECIFIED FORMNATURAL ESSENTIALS, INC.9926f733-1506-4224-9d70-b1813cd81ec32024-07-08WarningsExact 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