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 81 of 153 · 3,057 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join PROHEAL HYDROCORTISONE 1% MAXIMUM STRENGTH PLUS ALOE HYDROCORTISONE Click Industries LLC 328c389c-7e05-4892-a9b3-b6a753f4935a 2025-08-25 Warnings Exact identifier application number: M017 Yeheal CAMPHOR, MENTHOL, ISOPROPYL ALCOHOL Shenzhen Yeheal Biotechnology Co., Ltd 3cf1bc74-3060-6d63-e063-6294a90a9f5c 2025-08-22 Warnings Exact identifier application number: M017 Dermedial Anti-Ouch MENTHOL Natures Formulae Health Products Ltd. 3ce29160-3964-e435-e063-6394a90abb38 2025-08-21 Warnings Exact identifier application number: M017 SUGARLOAF ORGANICS MENTHOL REVIVE MENTHOL RENU LABORATORIES, LLC fa2f9539-b703-a00b-e053-6394a90ae309 2025-08-21 Warnings Exact identifier application number: M017 Camphor 4% Plus Menthol 10% CAMPHOR 4% PLUS MENTHOL 10% PureTek Corporation 3cab26e4-e377-f26a-e063-6394a90a17af 2025-08-20 Warnings Exact identifier application number: M017 Capsaicin 0.035% Cream CAPSAICIN 0.035% CREAM Puretekcorp 3cbc73b6-8c58-8f23-e063-6394a90a71a3 2025-08-20 Warnings Exact identifier application number: M017 Game On MENTHOL, METHYL SALICYLATE Natural Essentials, Inc. 3cd20f1f-033f-f698-e063-6294a90a89eb 2025-08-20 Warnings Exact identifier application number: M017 ELAIMEI Numbing Cream LIDOCAINE 4% Shenzhen Shandian Jingling Technology Co., Ltd. 37ac13b2-ca55-0e28-e063-6294a90a000e 2025-08-19 Warnings Exact identifier application number: M017 Calamine Plus Pramoxine HCl CALAMINE PLUS SPRAY FSA Store Inc. 3cd18f96-34f7-3f2c-e063-6294a90a3b7e 2025-08-19 Warnings Exact identifier application number: M017 Hydrocortisone HYDROCORTISONE SPRAY FSA Store Inc. 3ce24b87-55ac-0bbd-e063-6294a90ab582 2025-08-19 Warnings Exact identifier application number: M017 Fast Freeze Pain Relieving MENTHOL, UNSPECIFIED FORM NATURAL ESSENTIALS, INC. 15a26af1-ca5a-40fc-a411-6c0e8ae18fbb 2025-08-18 Warnings Exact identifier application number: M017 Orythia Maximum Strength Lidocaine Pain Relieving LIDOCAINE Planet (Anhui) Pharmaceutical Co., Ltd. 6d6b59f9-f614-4e3c-b07b-32b4591d39f2 2025-08-18 Warnings Exact identifier application number: M017 Ocean Potion Suncare Ice Plus Pain Relieving Soothing LIDOCAINE GNL BRANDS INTERNATIONAL, LLC 3c69654c-cba6-dfef-e063-6394a90ad479 2025-08-15 Warnings Exact identifier application number: M017 Earth Mama Medicated Herbal Lip Balm MENTHOL Eleeo Brands LLC 3c6c16bb-1f4b-b851-e063-6294a90a7404 2025-08-15 Warnings Exact identifier application number: M017 Lidocaine Hydrochloride LIDOCAINE HYDROCHLORIDE Cintas First Aid & Safety 96f17095-31f3-4b8a-ab22-0caaefaa7476 2025-08-15 Warnings Exact identifier application number: M017 MedPride Cold Ice Analgesic Gel MENTHOL SHIELD LINE LLC 860a2c86-b240-4e0e-e053-2a91aa0a333a 2025-08-15 Warnings Exact identifier application number: M017 MedPride Medicated Body Powder Powder MENTHOL, ZINC OXIDE Shield Line LLC cdb2fa5b-cf04-c876-e053-2a95a90a187c 2025-08-15 Warnings Exact identifier application number: M017 Burn LIDOCAINE HART Health c5ff392a-e788-43e0-91ea-5e0f8420586c 2025-08-15 Warnings Exact identifier application number: M017 Stopain Clinical MENTHOL Troy Manufacturing, Inc. 40df30ba-41ba-42b7-93fe-4183b57bdb00 2025-08-14 Warnings Exact identifier application number: M017 Signature Care Aloe Vera Gel with Lidocaine LIDOCAINE Safeway, Inc. d5069622-97b1-ba12-e053-2a95a90a7268 2025-08-14 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