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 60 of 153 · 3,057 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Sohm Pain Away MENTHOL, CAMPHOR SOHM, Inc 86632acf-80ae-48d7-a0bb-7ec980326bae 2025-11-25 Warnings Exact identifier application number: M017 HealthWise Lidocaine Pain Relief LIDOCAINE 4% Veridian Healthcare 6f2332c0-e078-40a8-9564-f47d21bc491b 2025-11-25 Warnings Exact identifier application number: M017 JUST CBD ROLL-ON WARMING CAMPHOR Just Brands LLC 44779065-5f57-8f01-e063-6394a90a3f8e 2025-11-25 Warnings Exact identifier application number: M017 JUST CBD ROLL-ON COOLING MENTHOL Just Brands LLC 44786cb6-176e-cc6e-e063-6394a90a54ad 2025-11-25 Warnings Exact identifier application number: M017 Diphenhydramine HCl and Zinc Acetate EXTRA STRENGTH ITCH RELIEF VALU MERCHANDISERS, CO 3e9c0f5b-cb76-475b-9a2b-39afa1eeb9ff 2025-11-24 Warnings Exact identifier application number: M017 Menthol MAXIMUM STRENGTH MEDICATED FOOT POWDER VALU MERCHANDISERS, CO 89a5c4bb-442f-d3f0-e053-2a95a90a51bd 2025-11-24 Warnings Exact identifier application number: M017 Dragon Pain Relieving Balm CAMPHOR, MENTHOL AMERICANNA WELLNESS, INC. 0d11ab8e-d3ea-c7ef-e063-6294a90ae0a3 2025-11-24 Warnings Exact identifier application number: M017 Dragon Pain Relieving CAMPHOR, MENTHOL AMERICANNA WELLNESS, INC. 0d113dec-8832-d984-e063-6394a90ae7b3 2025-11-24 Warnings Exact identifier application number: M017 Dragon Pain Relieving Balm CAMPHOR, MENTHOL AMERICANNA WELLNESS, INC. 0d12f03f-dd8b-0be5-e063-6294a90a43db 2025-11-24 Warnings Exact identifier application number: M017 Thermacare Heat Therapy Max Strength Lidocaine Pain Relief Gel THERMACARE HEAT THERAPY MAX STRENGTH LIDOCAINE PAIN RELIEF GEL Clarion Brands LLC 445db02a-c8e8-6ebb-e063-6294a90a4301 2025-11-24 Warnings Exact identifier application number: M017 Dragon Pain Relieving Balm CAMPHOR, MENTHOL AMERICANNA WELLNESS, INC. 0d129641-eaea-c3ee-e063-6394a90aa58f 2025-11-24 Warnings Exact identifier application number: M017 Dragon Pain Relieving CAMPHOR, MENTHOL AMERICANNA WELLNESS, INC. 0d1059cc-1b0b-4e7b-e063-6294a90a56ea 2025-11-24 Warnings Exact identifier application number: M017 GuruNanda Pain Relief MENTHOL AND CAMPHOR GURUNANDA, LLC 3ca78342-cc6d-5f6b-e063-6294a90a3f1c 2025-11-24 Warnings Exact identifier application number: M017 Dragon Pain Relieving CAMPHOR, MENTHOL AMERICANNA WELLNESS, INC. 0d118256-90ee-28ef-e063-6394a90a21e8 2025-11-24 Warnings Exact identifier application number: M017 health beyond HYDROCORTISONE Nantong Health & Beyond Hygienic Products Inc. bdcd5b01-f5e2-4519-bf4d-25e3cc7e67af 2025-11-23 Warnings Exact identifier application number: M017 NicDuic Quit Smoking Nicotine Patches 3 Step NICOTINE PATCHES Shenzhen Paxi Trading Co., Ltd. 4429fea8-46f8-8f7f-e063-6394a90a34b4 2025-11-22 Warnings Exact identifier application number: M017 NicDuic Quit Smoking Nicotine Patches 2 Step NICOTINE PATCHES Shenzhen Paxi Trading Co., Ltd. 442a926b-d7c1-4e35-e063-6394a90ad948 2025-11-22 Warnings Exact identifier application number: M017 NicDuic Quit Smoking Nicotine Patches 1 Step NICOTINE PATCHES Shenzhen Paxi Trading Co., Ltd. 442aae32-4ac6-5dd6-e063-6294a90aad02 2025-11-22 Warnings Exact identifier application number: M017 NicDuic Quit Smoking Nicotine Patches 1-3 Step 21MG NICOTINE PATCHES Shenzhen Paxi Trading Co., Ltd. 442ae0fa-a1ed-7901-e063-6294a90ab717 2025-11-22 Warnings Exact identifier application number: M017 IceQuake Lidocaine Analgesic LIDOCAINE HYDROCHLORIDE Dextrum Laboratories, Inc 441daa6f-f273-ac09-e063-6394a90a252c 2025-11-21 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