Home NDC 76314-002 FixMySkin Healing Balm Fragrance-Free
Product NDC 76314-002
11-digit product format 763140002
Labeler code 76314
Product ID 76314-002_2a934860-029e-a463-e063-6294a90aa446
Type HUMAN OTC DRUG
Nonproprietary name HYDROCORTISONE
Dosage form OINTMENT
Route TOPICAL
Labeler Lovely Skin, Inc.
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2009-12-31
Substance HYDROCORTISONE
Active strength 10 mg/mL
Pharmacologic classes Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
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 FixMySkin Healing Balm Fragrance-Free
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength HYDROCORTISONE 10 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination WI4X0X7BPJ Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 203105 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 76314-002-02 FixMySkin Healing Balm Fragrance-Free 7.39 mL in 1 PACKAGE OINTMENT 7.39 12 76314-002-03 FixMySkin Healing Balm Fragrance-Free 14.78 mL in 1 PACKAGE OINTMENT 14.78 12
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded HYDROCORTISONE ACTIVE INGREDIENT WI4X0X7BPJ FIXMYSKIN HEALING BALM FRAGRANCE-FREE (HYDROCORTISONE) OINTMENT [LOVELY SKIN, INC.] 2 HYDROCORTISONE ACTIVE MOIETY WI4X0X7BPJ FIXMYSKIN HEALING BALM FRAGRANCE-FREE (HYDROCORTISONE) OINTMENT [LOVELY SKIN, INC.] 2 ALKYL (C12-15) BENZOATE INACTIVE INGREDIENT A9EJ3J61HQ FIXMYSKIN HEALING BALM FRAGRANCE-FREE (HYDROCORTISONE) OINTMENT [LOVELY SKIN, INC.] 2 CASTOR OIL INACTIVE INGREDIENT D5340Y2I9G FIXMYSKIN HEALING BALM FRAGRANCE-FREE (HYDROCORTISONE) OINTMENT [LOVELY SKIN, INC.] 2 COCOA BUTTER INACTIVE INGREDIENT 512OYT1CRR FIXMYSKIN HEALING BALM FRAGRANCE-FREE (HYDROCORTISONE) OINTMENT [LOVELY SKIN, INC.] 2 MEADOWFOAM SEED OIL INACTIVE INGREDIENT 412ZHA4T4Y FIXMYSKIN HEALING BALM FRAGRANCE-FREE (HYDROCORTISONE) OINTMENT [LOVELY SKIN, INC.] 2 SHEANUT OIL INACTIVE INGREDIENT O88E196QRF FIXMYSKIN HEALING BALM FRAGRANCE-FREE (HYDROCORTISONE) OINTMENT [LOVELY SKIN, INC.] 2 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 FIXMYSKIN HEALING BALM FRAGRANCE-FREE (HYDROCORTISONE) OINTMENT [LOVELY SKIN, INC.] 2 SOYBEAN INACTIVE INGREDIENT L7HT8F1ZOD FIXMYSKIN HEALING BALM FRAGRANCE-FREE (HYDROCORTISONE) OINTMENT [LOVELY SKIN, INC.] 2 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ FIXMYSKIN HEALING BALM FRAGRANCE-FREE (HYDROCORTISONE) OINTMENT [LOVELY SKIN, INC.] 2 STEARYL ALCOHOL INACTIVE INGREDIENT 2KR89I4H1Y FIXMYSKIN HEALING BALM FRAGRANCE-FREE (HYDROCORTISONE) OINTMENT [LOVELY SKIN, INC.] 2 YELLOW WAX INACTIVE INGREDIENT 2ZA36H0S2V FIXMYSKIN HEALING BALM FRAGRANCE-FREE (HYDROCORTISONE) OINTMENT [LOVELY SKIN, INC.] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 76314-002 FIXMYSKIN HEALING BALM FRAGRANCE-FREE (HYDROCORTISONE) OINTMENT [LOVELY SKIN, INC.] 12 Current NDC, Legacy NDC, 2 package rows 20250101_c12af4c6-2f05-46ec-b901-1a4fcd750180.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 53 of 153 · 3,057 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join ZIMS MAX FREEZE LIDOCAINE HYDROCHLORIDE AND MENTHOL, KOBAYASHI Healthcare International, Inc. e364ff83-4aaf-4897-a7da-06581bc321f2 2025-12-18 Warnings Exact identifier application number: M017 Tiger Balm White Regular Strength CAMPHOR (SYNTHETIC) AND MENTHOL Haw Par Healthcare Ltd. f406161e-a9c4-47d1-8b21-93b1b7938063 2025-12-17 Warnings Exact identifier application number: M017 Resinol PETROLATUM AND RESORCINOL ResiCal, Inc. 03f57a4a-f94b-4ba6-b709-41cfb6e16261 2025-12-17 Warnings Exact identifier application number: M017 HealthWise Maximum Pain Relief LIDOCAINE Veridian Healthcare afc3c16d-0076-44b2-ae7e-5f36d4d8088e 2025-12-17 Warnings Exact identifier application number: M017 HealthWise Max Lidocaine plus Menthol LIDOCAINE, MENTHOL Veridian Healthcare f39a27da-6799-4fc6-97ca-101eac4a9360 2025-12-17 Warnings Exact identifier application number: M017 HealthWise Original Menthol MENTHOL Veridian Healthcare e4bfb6b0-545e-4fbc-8538-4f41a6be1025 2025-12-17 Warnings Exact identifier application number: M017 Welly Polka First Aid Kit HYDROCORTISONE, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE Dongguan Shenglian Tins Products Co., Ltd. d7c4314c-c4c6-4adf-b384-3ac7a7108319 2025-12-17 Warnings Exact identifier application number: M017 Frankincense and Myrrh Arthritis Pain Therapy MENTHOL Wise Consumer Products 2410a199-f4a3-da6c-e063-6394a90aaace 2025-12-17 Warnings Exact identifier application number: M017 Lidocaine LIDOCAINE, MENTHOL Vive Health LLC 462d3b24-643e-91da-e063-6394a90a0e1d 2025-12-17 Warnings Exact identifier application number: M017 Theragesic METHYL SALICYLATE Mission Pharmacal Company db6c0c77-0a20-d574-a98f-e6c9998b941f 2025-12-17 Warnings Exact identifier application number: M017 Teevodar Pain Relieving MENTHOL Sod-e Biotech Ltd 205b0fef-4f00-db2e-e063-6294a90a93b8 2025-12-17 Warnings Exact identifier application number: M017 Frankincense and Myrrh Arthritis Pain Relief MENTHOL WISE CONSUMER PRODUCTS CO. 116045df-891b-f370-e063-6294a90abe42 2025-12-17 Warnings Exact identifier application number: M017 Frankincense and Myrrh Intensive Foot Therapy MENTHOL Wise Consumer Products 23e56c6b-0f2b-721f-e063-6394a90a1ed0 2025-12-17 Warnings Exact identifier application number: M017 Tiger Balm Ultra Strength CAMPHOR (SYNTHETIC) AND MENTHOL Haw Par Healthcare Ltd. f0561804-e0f7-495d-9768-9b86a208c51e 2025-12-17 Warnings Exact identifier application number: M017 Kwan Loong METHYL SALICYLATE AND MENTHOL Haw Par Healthcare Ltd. 54bcb26e-786a-403e-9330-11ae9e3c013a 2025-12-17 Warnings Exact identifier application number: M017 Magsoothium Body Cooling Formula MENTHOL Ubu/Elements, Inc. f7fb6ac9-a920-a440-e053-6394a90aaa35 2025-12-16 Warnings Exact identifier application number: M017 Magsoothium CBD Body Lavender MENTHOL Ubu/Elements, Inc. f9b87fbe-b889-67a1-e053-6394a90acbcd 2025-12-16 Warnings Exact identifier application number: M017 Aquaphor Itch Relief HYDROCORTISONE Beiersdorf Inc b1d0333f-ba60-35d8-e053-2995a90af932 2025-12-16 Warnings Exact identifier application number: M017 Magsoothium CBD Body MENTHOL Ubu/Elements, Inc. 00b2ef34-42d7-523c-e063-6294a90a753d 2025-12-16 Warnings Exact identifier application number: M017 GENTLECARE HAND AND SKIN SANITIZER BENZALKONIUM CHLORIDE PARAGON SOLUTIONS US, INC. 16650277-fa62-485e-9a82-7763d2b50168 2025-12-16 Warnings Exact identifier application number: M017
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 76314-002-02 76314000202 7.39 mL in 1 PACKAGE (76314-002-02) 7.39 ml 2011-11-17 0000-00-00 No No Current 76314-002-03 76314000203 14.78 mL in 1 PACKAGE (76314-002-03) 14.78 ml 2011-11-17 0000-00-00 No No Current