FDA.reportPublic FDA data

FixMySkin Healing Balm Vanilla Flavor

Product NDC
76314-004
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
IngredientStrength
HYDROCORTISONE10 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
WI4X0X7BPJInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
203105Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
52f7a561-a0b5-4562-a588-d74fd874b83aAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
15bd4439-874a-4934-9954-248e5455d460Product name120260310
9962b773-9f2e-22cc-0032-535e48ac417bProduct name320250724
56bb0587-1bf2-48b2-9d93-fc9f59d1eeb2Product name120250325
4d56e8eb-d741-d4a5-de3f-2bab1af75a60Product name720220608
626d7260-31b5-4412-84fd-579746adb6b3Product name120210513
8a011600-5e61-4c59-ab7b-54ab658a3b71Product name220181127
a919621a-248d-3c7a-1084-9f9ce286fdfdProduct name220181009
e7d5a174-836b-a0af-b014-cb0826c69ddcProduct name220181004
fcce390d-6460-4701-87cf-940d8800a1c3Product name220180212
bf065fa6-1e3b-e4c3-0bde-2dc842ceeea1Product name220150218
02657a3f-1489-66ea-f740-5ab9524e57d7Product name120140508
26f3d783-2cc1-4327-e77d-71804cf675a2Product name120140508
36fdc54c-bbeb-981e-8a53-4d768e283892Product name120140508
58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8Product name120140508
61e59a42-186b-9f4b-aec3-fb49a6debc31Product name120140508
705740e1-dee5-2610-c5a3-4c59cd9d62afProduct name120140508
7bdc4804-3832-c0df-e519-72b6d47c9792Product name120140508
a7051cba-790b-a699-81f8-dbbbdbd9b5acProduct name120140508
abaf203f-619e-f265-559f-8c81af5cb1c2Product name120140508
acc4d8bb-0e29-e9f8-65f8-31e94184a9c0Product name120140508
b045ad64-0f28-9a02-2f9b-b34d94fb2278Product name120140508
bfd28ffb-d550-3fe9-f65b-10bcb7f971fdProduct name120140508
da108d9e-edc8-17a3-8c28-3251c6a8acccProduct name120140508
fe21f3fd-a378-0654-1972-db3c3b64470eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76314-004-01FixMySkin Healing Balm Vanilla Flavor4.43 mL in 1 PACKAGEOINTMENT4.439
76314-004-02FixMySkin Healing Balm Vanilla Flavor1 mL in 1 PACKETOINTMENT19

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HYDROCORTISONEACTIVE INGREDIENTWI4X0X7BPJFIXMYSKIN HEALING BALM VANILLA FLAVOR (HYDROCORTISONE) OINTMENT [LOVELY SKIN, INC.]2
HYDROCORTISONEACTIVE MOIETYWI4X0X7BPJFIXMYSKIN HEALING BALM VANILLA FLAVOR (HYDROCORTISONE) OINTMENT [LOVELY SKIN, INC.]2
ALKYL (C12-15) BENZOATEINACTIVE INGREDIENTA9EJ3J61HQFIXMYSKIN HEALING BALM VANILLA FLAVOR (HYDROCORTISONE) OINTMENT [LOVELY SKIN, INC.]2
CASTOR OILINACTIVE INGREDIENTD5340Y2I9GFIXMYSKIN HEALING BALM VANILLA FLAVOR (HYDROCORTISONE) OINTMENT [LOVELY SKIN, INC.]2
COCOA BUTTERINACTIVE INGREDIENT512OYT1CRRFIXMYSKIN HEALING BALM VANILLA FLAVOR (HYDROCORTISONE) OINTMENT [LOVELY SKIN, INC.]2
MEADOWFOAM SEED OILINACTIVE INGREDIENT412ZHA4T4YFIXMYSKIN HEALING BALM VANILLA FLAVOR (HYDROCORTISONE) OINTMENT [LOVELY SKIN, INC.]2
SHEANUT OILINACTIVE INGREDIENTO88E196QRFFIXMYSKIN HEALING BALM VANILLA FLAVOR (HYDROCORTISONE) OINTMENT [LOVELY SKIN, INC.]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4FIXMYSKIN HEALING BALM VANILLA FLAVOR (HYDROCORTISONE) OINTMENT [LOVELY SKIN, INC.]2
SOYBEANINACTIVE INGREDIENTL7HT8F1ZODFIXMYSKIN HEALING BALM VANILLA FLAVOR (HYDROCORTISONE) OINTMENT [LOVELY SKIN, INC.]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJFIXMYSKIN HEALING BALM VANILLA FLAVOR (HYDROCORTISONE) OINTMENT [LOVELY SKIN, INC.]2
STEARYL ALCOHOLINACTIVE INGREDIENT2KR89I4H1YFIXMYSKIN HEALING BALM VANILLA FLAVOR (HYDROCORTISONE) OINTMENT [LOVELY SKIN, INC.]2
VANILLAINACTIVE INGREDIENTQ74T35078HFIXMYSKIN HEALING BALM VANILLA FLAVOR (HYDROCORTISONE) OINTMENT [LOVELY SKIN, INC.]2
YELLOW WAXINACTIVE INGREDIENT2ZA36H0S2VFIXMYSKIN HEALING BALM VANILLA FLAVOR (HYDROCORTISONE) OINTMENT [LOVELY SKIN, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76314-004FIXMYSKIN HEALING BALM VANILLA FLAVOR (HYDROCORTISONE) OINTMENT [LOVELY SKIN, INC.]6Current NDC, Legacy NDC, 2 package rows20250101_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 8 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lidocaine 4% PatchLIDOCAINEAldermed Inc.57994923-20fc-9d9d-e063-6394a90a22c92026-07-27WarningsExact identifier
application number: M017
Lidocaine 4% PatchLIDOCAINEAldermed Inc.579a5012-837a-828b-e063-6294a90a4fb22026-07-27WarningsExact identifier
application number: M017
Original Pain ReliefTOPICAL ANALGESIC LOTIONReal Time Pain Relief Inc579bd303-9a50-4d66-e063-6294a90a61412026-07-27WarningsExact identifier
application number: M017
Lidfix Pain Relief Patch LidocaineLIDOCAINEHETERO HEALTHCARE LIMITED2149f0e3-1983-4f02-929e-ecd20357f4bb2026-07-27WarningsExact identifier
application number: M017
RectoProtectLIDOCAINEAkron Pharma Inc.1ca7d6cf-85a1-41a6-a07f-cff06a7edfbb2026-07-27WarningsExact identifier
application number: M017
OWELL NATURALS MAXIMUM STRENGTH LEG PAIN RELIEFMENTHOLOWELL NATURAL 8 LLC57a124b4-66c6-2474-e063-6294a90ab0d72026-07-27WarningsExact identifier
application number: M017
Icy Hot Performance DryMENTHOL 16%, CAMPHOR 11%Chattem, Inc.8927570f-761b-4d83-8612-30077224fdb82026-07-27WarningsExact identifier
application number: M017
NUMBINGLIDOCAINEYIYANGYUAN LIFE SCIENCES (HONG KONG) CO., LIMITED578675e8-30e7-6986-e063-6394a90a8afe2026-07-26WarningsExact identifier
application number: M017
Do Me Delay CreamBENZOCAINEProdigy Media53d5cd6b-96b8-9ba2-e063-6294a90a0d152026-07-24WarningsExact identifier
application number: M017
Bravado Labs Delay CreamBENZOCAINEProdigy Media Inc57269544-9cfb-4ff0-e063-6394a90adb022026-07-24WarningsExact identifier
application number: M017
Zytherial Lidocaine 4% Pain Relief PatchLIDOCAINE 4% PAIN RELIEF PATCHWenzhou Yuyuan Pharmaceutical Co., Ltd.56db5028-b631-7981-e063-6294a90ae3952026-07-24WarningsExact identifier
application number: M017
AEROBURNLIDOCAINE HYDROCHLORIDEAero Healthcare US LLCf8fa72db-5f7a-4158-a2b3-f8bc0e12df9f2026-07-24WarningsExact identifier
application number: M017
AEROSOOTHEHYDROCORTISONEAero Healthcare US LLC22b172a2-07e8-4ebb-b0a0-dfe4f25477fa2026-07-24WarningsExact identifier
application number: M017
Lidocaine Plus Pain RelievingLIDOCAINE HYDROCHLORIDE, BENZYL ALCOHOLCVS Pharmacy49003aac-184c-ae33-e063-6294a90a29c02026-07-24WarningsExact identifier
application number: M017
Arlun Lidocaine CreamLIDOCAINE CREAMGuangzhou Jingliang Cosmetics Co., Ltd.5765fbf1-e835-a11e-e063-6394a90a5ac22026-07-24WarningsExact identifier
application number: M017
DERMFREE PAIN RELIEFARNICA MONTANA HPUS 7% PAIN RELIEFJiangxi Yudexi Pharmaceutical Co., LTD4bb74112-c4e7-7988-e063-6394a90ae3f12026-07-24WarningsExact identifier
application number: M017
SERYNTH HEMORRHOIDLIDOCAINE 4% PHENYLEPHRINE HCL 0.25% HEMORRHOIDJiangxi Yudexi Pharmaceutical Co., LTD4c667f3d-1238-2f02-e063-6394a90ab7422026-07-24WarningsExact identifier
application number: M017
DERMFREE NUMBINGMENTHOL 5% NUMBINGJiangxi Yudexi Pharmaceutical Co., LTD4ca7222b-d754-9861-e063-6294a90a1b7b2026-07-24WarningsExact identifier
application number: M017
REINREUDE BACK PAIN THERAPYCAMPHOR 80MG MENTHOL 24MG CAPSICUM EXTRACT 16MG BACK PAIN THERAPYJiangxi Yudexi Pharmaceutical Co., LTD4ca7d0ca-6407-1fed-e063-6394a90aaccc2026-07-24WarningsExact identifier
application number: M017
SERYNTH NICOTINE TRANSDERMAL STOP SMOKING AIDNICOTINE21MG NICOTINE TRANSDERMAL STOP SMOKING AIDJiangxi Yudexi Pharmaceutical Co., LTD4d5821f9-605e-5391-e063-6294a90afcd22026-07-24WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
203105hydrocortisone 1 % Topical OintmentPSN52f7a561-a0b5-4562-a588-d74fd874b83a9
203105hydrocortisone 0.01 MG/MG Topical OintmentSCD52f7a561-a0b5-4562-a588-d74fd874b83a9
203105hydrocortisone 1 % Topical OintmentSY52f7a561-a0b5-4562-a588-d74fd874b83a9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
76314-004-01763140004014.43 mL in 1 PACKAGE (76314-004-01) 4.43 ml2011-11-170000-00-00NoNoCurrent
76314-004-02763140004021 mL in 1 PACKET (76314-004-02) 1 ml2011-11-17NoNoCurrent