Sunmark Hydrocortisone with Aloe

Product NDC
49348-521
Requested package NDC
49348-521-72
11-digit product format
493480521
Labeler code
49348
Product ID
49348-521_23ad9473-1b9c-c752-e063-6394a90af186
Type
HUMAN OTC DRUG
Nonproprietary name
Hydrocortisone
Dosage form
CREAM
Route
TOPICAL
Labeler
Strategic Sourcing Services LLC
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
1995-08-23
Marketing end
2026-07-31
Substance
HYDROCORTISONE
Active strength
1 g/100g
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag
No
Current FDA listing
Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage49348-52149348-521-72DDiscontinued by firm2026-09-14

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
49348-521-72Sunmark Hydrocortisone with AloeMaximum Strength1 in 1 CARTONCREAM14
49348-521-72Sunmark Hydrocortisone with AloeMaximum Strength28.4 g in 1 TUBECREAM28.44
49348-521-78Sunmark Hydrocortisone with AloeMaximum Strength60 g in 1 TUBECREAM604
49348-521-78Sunmark Hydrocortisone with AloeMaximum Strength1 in 1 CARTONCREAM14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49348-521-72GM - Gram49348-521c50e538a-f66a-41a9-8c23-b297a6a2298a12014-05-02
49348-521-78GM - Gram49348-521564d11b5-1f1a-4fa9-b53e-b0d26685c72c12016-06-14

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HydrocortisoneACTIVE INGREDIENTWI4X0X7BPJSUNMARK HYDROCORTISONE WITH ALOE MAXIMUM STRENGTH (HYDROCORTISONE) CREAM [MCKESSON]2
HydrocortisoneACTIVE MOIETYWI4X0X7BPJSUNMARK HYDROCORTISONE WITH ALOE MAXIMUM STRENGTH (HYDROCORTISONE) CREAM [MCKESSON]2
aloe vera leafINACTIVE INGREDIENTZY81Z83H0XSUNMARK HYDROCORTISONE WITH ALOE MAXIMUM STRENGTH (HYDROCORTISONE) CREAM [MCKESSON]2
cetostearyl alcoholINACTIVE INGREDIENT2DMT128M1SSUNMARK HYDROCORTISONE WITH ALOE MAXIMUM STRENGTH (HYDROCORTISONE) CREAM [MCKESSON]2
citric acid monohydrateINACTIVE INGREDIENT2968PHW8QPSUNMARK HYDROCORTISONE WITH ALOE MAXIMUM STRENGTH (HYDROCORTISONE) CREAM [MCKESSON]2
glycerinINACTIVE INGREDIENTPDC6A3C0OXSUNMARK HYDROCORTISONE WITH ALOE MAXIMUM STRENGTH (HYDROCORTISONE) CREAM [MCKESSON]2
glyceryl monostearateINACTIVE INGREDIENT230OU9XXE4SUNMARK HYDROCORTISONE WITH ALOE MAXIMUM STRENGTH (HYDROCORTISONE) CREAM [MCKESSON]2
methylparabenINACTIVE INGREDIENTA2I8C7HI9TSUNMARK HYDROCORTISONE WITH ALOE MAXIMUM STRENGTH (HYDROCORTISONE) CREAM [MCKESSON]2
mineral oilINACTIVE INGREDIENTT5L8T28FGPSUNMARK HYDROCORTISONE WITH ALOE MAXIMUM STRENGTH (HYDROCORTISONE) CREAM [MCKESSON]2
paraffinINACTIVE INGREDIENTI9O0E3H2ZESUNMARK HYDROCORTISONE WITH ALOE MAXIMUM STRENGTH (HYDROCORTISONE) CREAM [MCKESSON]2
propylparabenINACTIVE INGREDIENTZ8IX2SC1OHSUNMARK HYDROCORTISONE WITH ALOE MAXIMUM STRENGTH (HYDROCORTISONE) CREAM [MCKESSON]2
sodium cetostearyl sulfateINACTIVE INGREDIENT7ZBS06BH4BSUNMARK HYDROCORTISONE WITH ALOE MAXIMUM STRENGTH (HYDROCORTISONE) CREAM [MCKESSON]2
sodium lauryl sulfateINACTIVE INGREDIENT368GB5141JSUNMARK HYDROCORTISONE WITH ALOE MAXIMUM STRENGTH (HYDROCORTISONE) CREAM [MCKESSON]2
stearyl alcoholINACTIVE INGREDIENT2KR89I4H1YSUNMARK HYDROCORTISONE WITH ALOE MAXIMUM STRENGTH (HYDROCORTISONE) CREAM [MCKESSON]2
waterINACTIVE INGREDIENT059QF0KO0RSUNMARK HYDROCORTISONE WITH ALOE MAXIMUM STRENGTH (HYDROCORTISONE) CREAM [MCKESSON]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49348-521SUNMARK HYDROCORTISONE WITH ALOE MAXIMUM STRENGTH (HYDROCORTISONE) CREAM [STRATEGIC SOURCING SERVICES LLC]4Current NDC, Legacy NDC, 4 package rows20241006_e9180433-4e6e-40d9-807b-1e3dd8c22e0d.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 1 of 157 · 3,129 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
JenGufun LIDOCAINE KNEE PatchLIDOCAINE KNEE PATCHHenan Kangdi Medical Devices Co., Ltd.5b1d8508-b993-7a8d-e063-6294a90ae3062026-09-10WarningsExact identifier
application number: M017
Wart Corn RemoverSALICYLIC ACIDHONG KONG FOREVER YOUNG TRADING CO., LIMITED5b0cd6e0-f220-4ebd-e063-6294a90ade672026-09-09WarningsExact identifier
application number: M017
Magic CreamPAIN RELIEVING OINTMENTJiangxi Baikang Medical Products Co., Ltd.5b0f2515-47e9-603f-e063-6294a90af9d42026-09-09WarningsExact identifier
application number: M017
Burn GelLIDOCAINE HCITrifecta Pharmaceuticals USA LLCe9d3e9be-1036-fad0-e053-2a95a90a6efe2026-09-09WarningsExact identifier
application number: M017
4% Lidocaine Pain Relief PatchLIDOCAINE 4%Guangxi Keyun E-commerce Co., Ltd.5b197cd8-542f-38b4-e063-6294a90ad7d32026-09-09WarningsExact identifier
application number: M017
Pain Relieving Lidocaine PatchLIDOCAINEYYBA CORPaf8c84fd-224c-72b3-e053-2a95a90a95682026-09-07WarningsExact identifier
application number: M017
American Safety First AidLIDOCAINE HCLOrazen Incea2f776b-dfd0-6ce4-e053-2995a90af0092026-09-07WarningsExact identifier
application number: M017
MEDI-FIRST Topical AnalgesicLIDOCAINE HCIUltra Distributors Incb6f288f7-9ae3-215e-e053-2a95a90aedf62026-09-07WarningsExact identifier
application number: M017
MEDI-FIRSTBENZALKONIUM CHLORIDE, LIDOCAINEOrazen Incf508434f-5948-7134-e053-2a95a90a03d72026-09-05WarningsExact identifier
application number: M017
MEDI-FIRSTBENZALKONIUM CHLORIDE, LIDOCAINEOrazen Incf522fb0b-3d86-b228-e053-2a95a90a55e92026-09-05WarningsExact identifier
application number: M017
SurviveX Anti-itch CreamSURVIVEX HYDROCORTISONENantong Health & Beyond Hygienic Products Inc.5a7a1141-d3b1-0ee8-e063-6294a90a16aa2026-09-04WarningsExact identifier
application number: M017
NeuroNesic Pain Relieving CreamCAPSAICINBlaine Labs Inc.7107c13d-bf59-4c0a-84fe-725a9fca26912026-09-04WarningsExact identifier
application number: M017
FREEZE EASEMENTHOL 4%Global America Group LLC16553eda-ec34-485a-a11c-f51260efd9fa2026-09-03WarningsExact identifier
application number: M017
Neoteric Diabetic Skin Care 1 oz.DIMETHICONERNA PHARMA LLC5a944486-9591-f583-e063-6394a90aa04b2026-09-03WarningsExact identifier
application number: M017
Equate Menthol Pain RelievingMENTHOLWal-Mart Stores Incd5b0a7f1-4e23-426b-bb7e-aaa251ad4ffc2026-09-03WarningsExact identifier
application number: M017
ZHI TechnologiesLIDOCAINE, MENTHOLZHI Technologies, Inc.6717e995-4d2d-49e8-8ecf-7c62557dfdef2026-09-03WarningsExact identifier
application number: M017
Komxsum LIDOCAINE CreamLIDOCAINE 4% CREAMWenzhou Yuyuan Pharmaceutical Co., Ltd.5a9feae0-9be4-e736-e063-6294a90abe552026-09-03WarningsExact identifier
application number: M017
FREEZE EASE Roll-OnMENTHOLGlobal America Group LLC1869cc0d-a056-45de-aede-23b09b61ed122026-09-02WarningsExact identifier
application number: M017
Gaimoa Lidocaine Pain Relief Gel PatchesLIDOCAINE PAIN RELIEF GEL PATCHESHenan Enokon Medical Instrument Co., Ltd.5a68fe67-5c15-af9a-e063-6294a90a7ec12026-09-01WarningsExact identifier
application number: M017
CVS Cortisone LiquidHYDROCORTISONECVS Pharmacy42df45a9-d449-090a-e063-6394a90a9ee42026-09-01WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
106258hydrocortisone 1 % Topical CreamPSNe9180433-4e6e-40d9-807b-1e3dd8c22e0d4
106258hydrocortisone 10 MG/ML Topical CreamSCDe9180433-4e6e-40d9-807b-1e3dd8c22e0d4
106258hydrocortisone 1 % (as hydrocortisone acetate 1.2 % ) Topical CreamSYe9180433-4e6e-40d9-807b-1e3dd8c22e0d4
106258hydrocortisone 1 % Topical CreamSYe9180433-4e6e-40d9-807b-1e3dd8c22e0d4
106258hydrocortisone 1 GM per 100 GM Topical CreamSYe9180433-4e6e-40d9-807b-1e3dd8c22e0d4
106258hydrocortisone 1 % Topical CreamPSNbad20421-85a4-42c2-89db-254c3e2904ef1
106258hydrocortisone 10 MG/ML Topical CreamSCDbad20421-85a4-42c2-89db-254c3e2904ef1
106258hydrocortisone 1 % (as hydrocortisone acetate 1.2 % ) Topical CreamSYbad20421-85a4-42c2-89db-254c3e2904ef1
106258hydrocortisone 1 % Topical CreamSYbad20421-85a4-42c2-89db-254c3e2904ef1
106258hydrocortisone 1 GM per 100 GM Topical CreamSYbad20421-85a4-42c2-89db-254c3e2904ef1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49348-521-72493480521721 TUBE in 1 CARTON (49348-521-72) / 28.4 g in 1 TUBE1 tube2014-05-012026-07-31NoNoCurrent