FDA.reportPublic FDA data

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_6927ae99-b678-41a6-b1cb-b548fce8c565
Type
HUMAN OTC DRUG
Nonproprietary name
Hydrocortisone
Dosage form
CREAM
Route
TOPICAL
Labeler
Strategic Sourcing Services LLC
Application
part348
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
1995-08-23
Marketing end
0000-00-00
Substance
HYDROCORTISONE
Active strength
1 g/100g
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

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 firm2026-10-16

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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]4Legacy NDC, 4 package rows20241006_e9180433-4e6e-40d9-807b-1e3dd8c22e0d.zip

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 tube2014-05-010000-00-00NoNoCurrent