Home NDC 76314-004-01 FixMySkin Healing Balm Vanilla Flavor
Product NDC 76314-004
Requested package NDC 76314-004-01
11-digit product format 763140004
Labeler code 76314
Product ID 76314-004_5085327e-2b41-c7c1-e063-6394a90a4f3d
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 2011-11-17
Substance HYDROCORTISONE
Active strength 10 mg/mL
Pharmacologic classes Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag No
Listing certified through 2027-12-31
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 FixMySkin Healing Balm Vanilla Flavor
Listing expiration 2027-12-31 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 76314-004-01 FixMySkin Healing Balm Vanilla Flavor 4.43 mL in 1 PACKAGE OINTMENT 4.43 9 76314-004-02 FixMySkin Healing Balm Vanilla Flavor 1 mL in 1 PACKET OINTMENT 1 9
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded HYDROCORTISONE ACTIVE INGREDIENT WI4X0X7BPJ FIXMYSKIN HEALING BALM VANILLA FLAVOR (HYDROCORTISONE) OINTMENT [LOVELY SKIN, INC.] 2 HYDROCORTISONE ACTIVE MOIETY WI4X0X7BPJ FIXMYSKIN HEALING BALM VANILLA FLAVOR (HYDROCORTISONE) OINTMENT [LOVELY SKIN, INC.] 2 ALKYL (C12-15) BENZOATE INACTIVE INGREDIENT A9EJ3J61HQ FIXMYSKIN HEALING BALM VANILLA FLAVOR (HYDROCORTISONE) OINTMENT [LOVELY SKIN, INC.] 2 CASTOR OIL INACTIVE INGREDIENT D5340Y2I9G FIXMYSKIN HEALING BALM VANILLA FLAVOR (HYDROCORTISONE) OINTMENT [LOVELY SKIN, INC.] 2 COCOA BUTTER INACTIVE INGREDIENT 512OYT1CRR FIXMYSKIN HEALING BALM VANILLA FLAVOR (HYDROCORTISONE) OINTMENT [LOVELY SKIN, INC.] 2 MEADOWFOAM SEED OIL INACTIVE INGREDIENT 412ZHA4T4Y FIXMYSKIN HEALING BALM VANILLA FLAVOR (HYDROCORTISONE) OINTMENT [LOVELY SKIN, INC.] 2 SHEANUT OIL INACTIVE INGREDIENT O88E196QRF FIXMYSKIN HEALING BALM VANILLA FLAVOR (HYDROCORTISONE) OINTMENT [LOVELY SKIN, INC.] 2 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 FIXMYSKIN HEALING BALM VANILLA FLAVOR (HYDROCORTISONE) OINTMENT [LOVELY SKIN, INC.] 2 SOYBEAN INACTIVE INGREDIENT L7HT8F1ZOD FIXMYSKIN HEALING BALM VANILLA FLAVOR (HYDROCORTISONE) OINTMENT [LOVELY SKIN, INC.] 2 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ FIXMYSKIN HEALING BALM VANILLA FLAVOR (HYDROCORTISONE) OINTMENT [LOVELY SKIN, INC.] 2 STEARYL ALCOHOL INACTIVE INGREDIENT 2KR89I4H1Y FIXMYSKIN HEALING BALM VANILLA FLAVOR (HYDROCORTISONE) OINTMENT [LOVELY SKIN, INC.] 2 VANILLA INACTIVE INGREDIENT Q74T35078H FIXMYSKIN HEALING BALM VANILLA FLAVOR (HYDROCORTISONE) OINTMENT [LOVELY SKIN, INC.] 2 YELLOW WAX INACTIVE INGREDIENT 2ZA36H0S2V FIXMYSKIN HEALING BALM VANILLA FLAVOR (HYDROCORTISONE) OINTMENT [LOVELY SKIN, INC.] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 76314-004 FIXMYSKIN HEALING BALM VANILLA FLAVOR (HYDROCORTISONE) OINTMENT [LOVELY SKIN, INC.] 6 Current NDC, Legacy NDC, 2 package rows 20250101_52f7a561-a0b5-4562-a588-d74fd874b83a.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 71 of 152 · 3,029 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Signature Care Cold and Hot MENTHOL, AND METHYL SALICYLATE Safeway Inc. ab201023-e3dc-52ec-e053-2995a90a1f18 2025-10-24 Warnings Exact identifier application number: M017 HealthWise Medicated Cold Hot 5% Patch MENTHOL Veridian Healthcare 15aef56f-cd25-05ac-e063-6394a90a07bb 2025-10-23 Warnings Exact identifier application number: M017 Alivio LIDOCAINE Amerise Pharmaceuticals LLC eb3a98f1-c875-4f08-8b4b-44e22626b609 2025-10-23 Warnings Exact identifier application number: M017 Pain Relieveing Gel-Patch LIDOCAINE Bullet point LLC 41d507c4-ad37-2686-e063-6394a90aae5b 2025-10-23 Warnings Exact identifier application number: M017 ActivICE MENTHOL Medline Industries, LP 98fa9a34-0e1e-0997-e053-2a95a90ac77d 2025-10-23 Warnings Exact identifier application number: M017 Coralite Pain Relief Hot MENTHOL AND CAPSAICIN United Exchange Corporation 78eb133d-01bb-6466-e053-2991aa0accc0 2025-10-23 Warnings Exact identifier application number: M017 Americaine BENZOCAINE Insight Pharmaceuticals LLC 4fd14452-0285-40c4-b835-36935c2056b2 2025-10-23 Warnings Exact identifier application number: M017 zourunan PAIN RELIEF PAIN RELIEF Guchutang Biotechnology (Longyan) Co., Ltd 41bc1c0c-63d5-0d41-e063-6394a90a341b 2025-10-22 Warnings Exact identifier application number: M017 zourunan PAIN RELIEF PAIN RELIEF Guchutang Biotechnology (Longyan) Co., Ltd 41bd0769-6ba0-d0d5-e063-6294a90af7c9 2025-10-22 Warnings Exact identifier application number: M017 Coralite Extra Strength Pain Relief Sleeve Knee MENTHOL United Exchange Corp. aa5873bd-af64-41cc-8f16-7714c56bca96 2025-10-22 Warnings Exact identifier application number: M017 Family Care Muscle Rub CAMPHOR, MENTHOL, AND METHYL SALICYLATE United Exchange Corp. 63006bb5-76e8-eb64-e053-2991aa0a95ad 2025-10-22 Warnings Exact identifier application number: M017 Winco Cold and Hot Medicated Patch Large MENTHOL WINCO FOODS, LLC af0d86c4-f74e-2dbe-e053-2a95a90a74c1 2025-10-22 Warnings Exact identifier application number: M017 Coralite Cold and Hot MENTHOL United Exchange Corp. 064a6149-a0e2-8a73-e063-6394a90a7953 2025-10-22 Warnings Exact identifier application number: M017 Topical Analgesic MENTHOL Youngevity International Inc. b4693947-f5b3-6fd3-e053-2995a90ab581 2025-10-22 Warnings Exact identifier application number: M017 PAIN RELIEVING LIDOCAINE Medhome Pharma Inc 41cb1135-84e0-0c9a-e063-6294a90ada96 2025-10-22 Warnings Exact identifier application number: M017 KINKAN AMMONIA, CAMPHOR (NATURAL), MENTHOL KINKANDO CO., LTD . f2c0f3e1-792b-4798-bf6d-acd1bbefa261 2025-10-21 Warnings Exact identifier application number: M017 Coralite Muscle and Joint Pain Relief CAPSACIN United Exchange Corp. ba9a3d72-db7a-4dd0-9220-f43c9ed87114 2025-10-21 Warnings Exact identifier application number: M017 Coralite Extra Strength Pain Relief Sleeve Wrist MENTHOL United Exchange Corp. ae314478-b8ab-4e90-bd0a-7a882d5c1b2e 2025-10-21 Warnings Exact identifier application number: M017 Coralite Cold and Hot MENTHOL United Exchange Corp. 85bd7658-e951-7daf-e053-2a91aa0a9f54 2025-10-21 Warnings Exact identifier application number: M017 Family Care Maximum Strength Medicated Anti Itch MENTHOL United Exchange Corp. 430b5753-3087-4cb1-bf54-0eedc3f4b1d5 2025-10-21 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 76314-004-01 76314000401 4.43 mL in 1 PACKAGE (76314-004-01) 4.43 ml 2011-11-17 0000-00-00 No No Current