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
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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
9ff8db07-ad6d-4865-a534-94bd8312957e	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
15bd4439-874a-4934-9954-248e5455d460	Product name	1	20260310
9962b773-9f2e-22cc-0032-535e48ac417b	Product name	3	20250724
56bb0587-1bf2-48b2-9d93-fc9f59d1eeb2	Product name	1	20250325
4d56e8eb-d741-d4a5-de3f-2bab1af75a60	Product name	7	20220608
626d7260-31b5-4412-84fd-579746adb6b3	Product name	1	20210513
8a011600-5e61-4c59-ab7b-54ab658a3b71	Product name	2	20181127
a919621a-248d-3c7a-1084-9f9ce286fdfd	Product name	2	20181009
e7d5a174-836b-a0af-b014-cb0826c69ddc	Product name	2	20181004
fcce390d-6460-4701-87cf-940d8800a1c3	Product name	2	20180212
bf065fa6-1e3b-e4c3-0bde-2dc842ceeea1	Product name	2	20150218
02657a3f-1489-66ea-f740-5ab9524e57d7	Product name	1	20140508
26f3d783-2cc1-4327-e77d-71804cf675a2	Product name	1	20140508
36fdc54c-bbeb-981e-8a53-4d768e283892	Product name	1	20140508
58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8	Product name	1	20140508
61e59a42-186b-9f4b-aec3-fb49a6debc31	Product name	1	20140508
705740e1-dee5-2610-c5a3-4c59cd9d62af	Product name	1	20140508
7bdc4804-3832-c0df-e519-72b6d47c9792	Product name	1	20140508
a7051cba-790b-a699-81f8-dbbbdbd9b5ac	Product name	1	20140508
abaf203f-619e-f265-559f-8c81af5cb1c2	Product name	1	20140508
acc4d8bb-0e29-e9f8-65f8-31e94184a9c0	Product name	1	20140508
b045ad64-0f28-9a02-2f9b-b34d94fb2278	Product name	1	20140508
bfd28ffb-d550-3fe9-f65b-10bcb7f971fd	Product name	1	20140508
da108d9e-edc8-17a3-8c28-3251c6a8accc	Product name	1	20140508
fe21f3fd-a378-0654-1972-db3c3b64470e	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
76314-003-01	FixMySkin Healing Balm Unflavored	4.43 mL in 1 PACKAGE	OINTMENT	4.43		7
76314-003-02	FixMySkin Healing Balm Unflavored	1 mL in 1 PACKET	OINTMENT	1		7

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
HYDROCORTISONE	ACTIVE INGREDIENT	WI4X0X7BPJ	FIXMYSKIN HEALING BALM UNFLAVORED (HYDROCORTISONE) OINTMENT [LOVELY SKIN, INC.]	2
HYDROCORTISONE	ACTIVE MOIETY	WI4X0X7BPJ	FIXMYSKIN HEALING BALM UNFLAVORED (HYDROCORTISONE) OINTMENT [LOVELY SKIN, INC.]	2
ALKYL (C12-15) BENZOATE	INACTIVE INGREDIENT	A9EJ3J61HQ	FIXMYSKIN HEALING BALM UNFLAVORED (HYDROCORTISONE) OINTMENT [LOVELY SKIN, INC.]	2
CASTOR OIL	INACTIVE INGREDIENT	D5340Y2I9G	FIXMYSKIN HEALING BALM UNFLAVORED (HYDROCORTISONE) OINTMENT [LOVELY SKIN, INC.]	2
COCOA BUTTER	INACTIVE INGREDIENT	512OYT1CRR	FIXMYSKIN HEALING BALM UNFLAVORED (HYDROCORTISONE) OINTMENT [LOVELY SKIN, INC.]	2
MEADOWFOAM SEED OIL	INACTIVE INGREDIENT	412ZHA4T4Y	FIXMYSKIN HEALING BALM UNFLAVORED (HYDROCORTISONE) OINTMENT [LOVELY SKIN, INC.]	2
SHEANUT OIL	INACTIVE INGREDIENT	O88E196QRF	FIXMYSKIN HEALING BALM UNFLAVORED (HYDROCORTISONE) OINTMENT [LOVELY SKIN, INC.]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	FIXMYSKIN HEALING BALM UNFLAVORED (HYDROCORTISONE) OINTMENT [LOVELY SKIN, INC.]	2
SOYBEAN	INACTIVE INGREDIENT	L7HT8F1ZOD	FIXMYSKIN HEALING BALM UNFLAVORED (HYDROCORTISONE) OINTMENT [LOVELY SKIN, INC.]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	FIXMYSKIN HEALING BALM UNFLAVORED (HYDROCORTISONE) OINTMENT [LOVELY SKIN, INC.]	2
STEARYL ALCOHOL	INACTIVE INGREDIENT	2KR89I4H1Y	FIXMYSKIN HEALING BALM UNFLAVORED (HYDROCORTISONE) OINTMENT [LOVELY SKIN, INC.]	2
YELLOW WAX	INACTIVE INGREDIENT	2ZA36H0S2V	FIXMYSKIN HEALING BALM UNFLAVORED (HYDROCORTISONE) OINTMENT [LOVELY SKIN, INC.]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
76314-003	FIXMYSKIN HEALING BALM UNFLAVORED (HYDROCORTISONE) OINTMENT [LOVELY SKIN, INC.]	6	Current NDC, Legacy NDC, 2 package rows	20250101_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 152 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Bactine Max Lidocaine Roll-on 2.5oz	LIDOCAINE	WellSpring Pharmaceutical Corporation	09b32a98-9131-451e-87a6-81a1e4ed7ec5	2023-04-25	Warnings	Exact identifier application number: M017
Icy Hot Pro Dry	CAMPHOR, MENTHOL	Chattem, Inc.	4de1bc29-d166-4599-9e75-5f841bf20967	2023-03-01	Warnings	Exact identifier application number: M017
Icy Hot Vanishing Scent	MENTHOL	Chattem, Inc.	e2092016-9741-433d-92e6-74bfddadb72c	2022-09-29	Warnings	Exact identifier application number: M017
New Terocin	METHYL SALICYLATE, CAPSAICIN, AND MENTHOL	Alexso, Inc	5dbd5fc0-a27e-4979-aca7-28f73096fd5f	2022-08-18	Warnings	Exact identifier application number: M017
FIRSTAR Sting Relief Pad	BENZOCAINE	JIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD.	0e491a7a-4204-439f-862d-741cbc0be9fd	2021-07-06	Warnings	Exact identifier application number: M017
Arthritis Relief GoodSense	TROLAMINE SALICYLATE	Geiss, Destin & Dunn, Inc	a253730a-2187-07de-e053-2a95a90a9877	2020-04-02	Warnings	Exact identifier application number: M017
Aloe Cort	HYDROCORTISONE	Topiderm, Inc.	789a6669-3320-4558-8d6f-ab255db50d8d	2019-09-17	Warnings	Exact identifier application number: M017
Eagle Brand Medicated Roll On Refresh	CAMPHOR, MENTHOL	Borden Company (Private) Limited	567b6820-fb52-630e-e063-6294a90a8bf8	2015-07-01	Warnings	Exact identifier application number: M017
Eagle Brand Medicated Oil Aromatic	CAMPHOR, MENTHOL, METHYL SALICYLATE	Borden Company (Private) Limited	54e45d89-e8c3-6fc3-e063-6394a90aac4e	2015-06-15	Warnings	Exact identifier application number: M017

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
WI4X0X7BPJ	HYDROCORTISONE	50-23-7	HYDROCORTISONE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
203105	hydrocortisone 1 % Topical Ointment	PSN	9ff8db07-ad6d-4865-a534-94bd8312957e	7
203105	hydrocortisone 0.01 MG/MG Topical Ointment	SCD	9ff8db07-ad6d-4865-a534-94bd8312957e	7
203105	hydrocortisone 1 % Topical Ointment	SY	9ff8db07-ad6d-4865-a534-94bd8312957e	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
76314-003-01	76314000301	4.43 mL in 1 PACKAGE (76314-003-01)	4.43 ml	2011-11-17	0000-00-00	No	No	Current
76314-003-02	76314000302	1 mL in 1 PACKET (76314-003-02)	1 ml	2011-11-17		No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
FixMySkin Healing Balm Unflavored	Lovely Skin, Inc. \| Topical Pharmaceuticals Inc.	2026-04-23	HUMAN OTC DRUG LABEL	7