FixMySkin Healing Balm Unflavored

Product NDC
76314-003
11-digit product format
763140003
Labeler code
76314
Product ID
76314-003_502555d0-907a-6275-e063-6394a90a0352
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 Unflavored
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
9ff8db07-ad6d-4865-a534-94bd8312957eAvailable 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
76314-003-01FixMySkin Healing Balm Unflavored4.43 mL in 1 PACKAGEOINTMENT4.437
76314-003-02FixMySkin Healing Balm Unflavored1 mL in 1 PACKETOINTMENT17

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76314-003FIXMYSKIN HEALING BALM UNFLAVORED (HYDROCORTISONE) OINTMENT [LOVELY SKIN, INC.]6Current NDC, Legacy NDC, 2 package rows20250101_9ff8db07-ad6d-4865-a534-94bd8312957e.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 74 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Nufabrx Medicine Infused SocksCAPSAICINNufabrx LLC00d7d5bf-ee03-e73d-e063-6394a90a5d942025-10-15WarningsExact identifier
application number: M017
Nufabrx Medicine Infused Elbow SleeveCAPSAICINNufabrx LLC27ef3ef0-2f98-6672-e063-6294a90aeca42025-10-15WarningsExact identifier
application number: M017
Nufabrx Medicine Infused Wrist SleeveCAPSAICINNufabrx LLC22572cf9-fc0c-d327-e063-6394a90a21862025-10-15WarningsExact identifier
application number: M017
Antibacterial Lidocaine Wound GelBENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDEWALGREENSeff77965-dc7f-49af-e053-2995a90a1a972025-10-14WarningsExact identifier
application number: M017
Pleasure Balm Kama SutraBENZOCAINECosmetic Enterprises Ltdf370e3c4-65ca-4f3c-a5aa-70e198e681a22025-10-14WarningsExact identifier
application number: M017
Vanicream HC Anti-ItchHYDROCORTISONEPharmaceutical Specialties, Inc.28b06507-27a5-2cb1-e054-00144ff8d46c2025-10-14WarningsExact identifier
application number: M017
TrilogelLIDOCAINE HYDROCHLORIDETrifluent Pharma LLC22af7d63-6a56-4a38-a95b-0f88410b23cb2025-10-14WarningsExact identifier
application number: M017
PROINNATE Numbing CreamMENTHOLGuangzhou Haishi Biological Technology Co., Ltd.40c63645-8ed3-82b3-e063-6294a90a52672025-10-13WarningsExact identifier
application number: M017
CramergesicMENTHOL, METHYL SALICYLATEThe Hygenic Company, LLCd0ffde7a-6942-74fc-e053-2a95a90a484a2025-10-13WarningsExact identifier
application number: M017
TricylateMENTHOL, UNSPECIFIED FORM AND METHYL SALICYLATETrifluent Pharma LLC4869b63a-e01e-4a79-a493-7a1b4d3e914b2025-10-13WarningsExact identifier
application number: M017
Doloflex Pain ReliefMENTHOL, METHYL SALICYLATEUnited Health & Beauty Corp32a830cc-04d3-102e-e063-6294a90a1cad2025-10-12WarningsExact identifier
application number: M017
Lidocaine Pain Relieving Gel-PatchLIDOCAINENanjing Anxing Medical Technology Co., Ltd.40c9b132-57ce-865e-e063-6394a90a20802025-10-10WarningsExact identifier
application number: M017
KinesysZINC OXIDEWilc Healthcare Inca32b44c3-eda0-48ea-95fc-250a2c2396ca2025-10-10WarningsExact identifier
application number: M017
Te-Fu Recovery MassageMENTHOL, METHYL SALICYLATEWasatch Product Development7bc2989f-dfb6-e8af-e053-2991aa0a0bf22025-10-10WarningsExact identifier
application number: M017
Anti-itchHYDROCORTISONEMedline Industries, LPb0947381-c0db-4253-ab40-3d45603ae65d2025-10-09WarningsExact identifier
application number: M017
Kalaya Pain ReliefMETHYL SALICYLATE, MENTHOL, CAMPHORAvaria Health & Beauty Corpe2452c4b-2548-497f-828b-5d960402522a2025-10-08WarningsExact identifier
application number: M017
Kalaya Pain Relief 6X with ArnicaPAIN RELIEF CREAMAvaria Health & Beauty Corp60198d2e-4de3-3fa0-e053-2a91aa0afaf72025-10-08WarningsExact identifier
application number: M017
KALAYA PAIN RELIEF 6X WITH ARNICA - Pain ReliefMETHYL SALICYLATE, MENTHOL, CAMPHORAvaria Health & Beauty Corp9b9b7cad-a5e2-4445-856b-4aa439d77a802025-10-08WarningsExact identifier
application number: M017
KALAYA FOAMING PAIN RELIEFMETHYL SALICYLATE, MENTHOL, CAMPHORAvaria Health & Beauty Corpd5021e6d-f29f-446b-874c-bdcabd9cf4f62025-10-08WarningsExact identifier
application number: M017
KALAYA EXTRA STRENGTH FOAMING PAIN RELIEFMETHYL SALICYLATE, MENTHOL, CAMPHORAvaria Health & Beauty Corpe0c9f22a-165a-4558-ba3c-8592f1bd00162025-10-08WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
203105hydrocortisone 1 % Topical OintmentPSN9ff8db07-ad6d-4865-a534-94bd8312957e7
203105hydrocortisone 0.01 MG/MG Topical OintmentSCD9ff8db07-ad6d-4865-a534-94bd8312957e7
203105hydrocortisone 1 % Topical OintmentSY9ff8db07-ad6d-4865-a534-94bd8312957e7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
76314-003-01763140003014.43 mL in 1 PACKAGE (76314-003-01) 4.43 ml2011-11-170000-00-00NoNoCurrent
76314-003-02763140003021 mL in 1 PACKET (76314-003-02) 1 ml2011-11-17NoNoCurrent