SUNMARK HYDROCORTISONE PLUS

Product NDC
49348-441
Requested package NDC
49348-441-72
11-digit product format
493480441
Labeler code
49348
Product ID
49348-441_23ad76a8-70d1-6b4f-e063-6394a90a0d79
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
1989-10-03
Marketing end
2026-05-31
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 packagepackage49348-44149348-441-72DDiscontinued by firm2026-08-11

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
60c52429-fcef-eb54-2387-43bc9e4f296bProduct 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
49348-441-72SUNMARK HYDROCORTISONE PLUS28.4 g in 1 TUBECREAM28.44
49348-441-72SUNMARK HYDROCORTISONE PLUS1 in 1 CARTONCREAM14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49348-441-72GM - Gram49348-441fb0c3cce-72c8-44d3-9111-69b9cd266b1f12013-02-19

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HydrocortisoneACTIVE INGREDIENTWI4X0X7BPJSUNMARK HYDROCORTISONE PLUS 12 MOISTURIZERS (HYDROCORTISONE) CREAM [MCKESSON]1
HydrocortisoneACTIVE MOIETYWI4X0X7BPJSUNMARK HYDROCORTISONE PLUS 12 MOISTURIZERS (HYDROCORTISONE) CREAM [MCKESSON]1
.alpha.-tocopherol acetateINACTIVE INGREDIENT9E8X80D2L0SUNMARK HYDROCORTISONE PLUS 12 MOISTURIZERS (HYDROCORTISONE) CREAM [MCKESSON]1
cetostearyl alcoholINACTIVE INGREDIENT2DMT128M1SSUNMARK HYDROCORTISONE PLUS 12 MOISTURIZERS (HYDROCORTISONE) CREAM [MCKESSON]1
chamomile flower oilINACTIVE INGREDIENT60F80Z61A9SUNMARK HYDROCORTISONE PLUS 12 MOISTURIZERS (HYDROCORTISONE) CREAM [MCKESSON]1
cholecalciferolINACTIVE INGREDIENT1C6V77QF41SUNMARK HYDROCORTISONE PLUS 12 MOISTURIZERS (HYDROCORTISONE) CREAM [MCKESSON]1
citric acid monohydrateINACTIVE INGREDIENT2968PHW8QPSUNMARK HYDROCORTISONE PLUS 12 MOISTURIZERS (HYDROCORTISONE) CREAM [MCKESSON]1
corn oilINACTIVE INGREDIENT8470G57WFMSUNMARK HYDROCORTISONE PLUS 12 MOISTURIZERS (HYDROCORTISONE) CREAM [MCKESSON]1
glycerinINACTIVE INGREDIENTPDC6A3C0OXSUNMARK HYDROCORTISONE PLUS 12 MOISTURIZERS (HYDROCORTISONE) CREAM [MCKESSON]1
glyceryl monostearateINACTIVE INGREDIENT230OU9XXE4SUNMARK HYDROCORTISONE PLUS 12 MOISTURIZERS (HYDROCORTISONE) CREAM [MCKESSON]1
isopropyl palmitateINACTIVE INGREDIENT8CRQ2TH63MSUNMARK HYDROCORTISONE PLUS 12 MOISTURIZERS (HYDROCORTISONE) CREAM [MCKESSON]1
maltodextrinINACTIVE INGREDIENT7CVR7L4A2DSUNMARK HYDROCORTISONE PLUS 12 MOISTURIZERS (HYDROCORTISONE) CREAM [MCKESSON]1
methylparabenINACTIVE INGREDIENTA2I8C7HI9TSUNMARK HYDROCORTISONE PLUS 12 MOISTURIZERS (HYDROCORTISONE) CREAM [MCKESSON]1
mineral oilINACTIVE INGREDIENTT5L8T28FGPSUNMARK HYDROCORTISONE PLUS 12 MOISTURIZERS (HYDROCORTISONE) CREAM [MCKESSON]1
paraffinINACTIVE INGREDIENTI9O0E3H2ZESUNMARK HYDROCORTISONE PLUS 12 MOISTURIZERS (HYDROCORTISONE) CREAM [MCKESSON]1
petrolatumINACTIVE INGREDIENT4T6H12BN9USUNMARK HYDROCORTISONE PLUS 12 MOISTURIZERS (HYDROCORTISONE) CREAM [MCKESSON]1
propylene glycolINACTIVE INGREDIENT6DC9Q167V3SUNMARK HYDROCORTISONE PLUS 12 MOISTURIZERS (HYDROCORTISONE) CREAM [MCKESSON]1
propylparabenINACTIVE INGREDIENTZ8IX2SC1OHSUNMARK HYDROCORTISONE PLUS 12 MOISTURIZERS (HYDROCORTISONE) CREAM [MCKESSON]1
sodium cetostearyl sulfateINACTIVE INGREDIENT7ZBS06BH4BSUNMARK HYDROCORTISONE PLUS 12 MOISTURIZERS (HYDROCORTISONE) CREAM [MCKESSON]1
sodium lauryl sulfateINACTIVE INGREDIENT368GB5141JSUNMARK HYDROCORTISONE PLUS 12 MOISTURIZERS (HYDROCORTISONE) CREAM [MCKESSON]1
stearyl alcoholINACTIVE INGREDIENT2KR89I4H1YSUNMARK HYDROCORTISONE PLUS 12 MOISTURIZERS (HYDROCORTISONE) CREAM [MCKESSON]1
Vitamin A palmitateINACTIVE INGREDIENT1D1K0N0VVCSUNMARK HYDROCORTISONE PLUS 12 MOISTURIZERS (HYDROCORTISONE) CREAM [MCKESSON]1
waterINACTIVE INGREDIENT059QF0KO0RSUNMARK HYDROCORTISONE PLUS 12 MOISTURIZERS (HYDROCORTISONE) CREAM [MCKESSON]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49348-441SUNMARK HYDROCORTISONE PLUS (HYDROCORTISONE) CREAM [STRATEGIC SOURCING SERVICES LLC]4Current NDC, Legacy NDC, 2 package rows20241006_ed6b197d-972a-455d-86be-bf2e8ec12b16.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 154 · 3,068 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Itch ReliefDIPHENHYDRAMINE HCL, ZINC ACETATECardinal Health, 110 dba Leader3ed7b8a1-012f-459d-878c-813b93d4673c2026-08-06Warnings, Adverse reactionsExact identifier
application number: M017
Gel Cooling Pain ReliefMENTHOLThe Kroger Co.6fb0acc8-8dab-452c-b09e-de97306e1c322026-08-06Warnings, Adverse reactionsExact identifier
application number: M017
Lidocaine Tattoo WipeLIDOCAINE HYDROCHLORIDEMD Tattoo Company369c1d16-597c-e1dc-e063-6394a90a31042026-08-06WarningsExact identifier
application number: M017
Point Relief Coldspot Pain RelievingMENTHOLFabrication Enterprises Inc479fb728-4aeb-42e3-b238-f04255514baa2026-08-05WarningsExact identifier
application number: M017
Lidocaine HClLIDOCAINE HCLTopco Associates LLC584e1f35-4d99-9c85-e063-6294a90ab3d02026-08-05Warnings, Adverse reactionsExact identifier
application number: M017
tuiwaro LIDOCAINE CreamLIDOCAINE CREAMGuangzhou Jingliang Cosmetics Co., Ltd.56e36592-a935-61d4-e063-6294a90a6e4c2026-08-04WarningsExact identifier
application number: M017
Mineral Ice Extreme Menthol Pain ReliefMENTHOLCarlin Consumer Health LLC584f5c6e-3385-3221-e063-6294a90aabae2026-08-04WarningsExact identifier
application number: M017
hydrocortisoneHYDROCORTISONEBryant Ranch Prepack484fe5e4-a058-49c0-a382-c8fc3e20c3b22026-08-04WarningsExact identifier
application number: M017
procureHYDROCORTISONE ACETATETWIN MED, LLC2670c9c4-66ad-40e8-a08a-582b160de39d2026-08-03WarningsExact identifier
application number: M017
Icy Hot Original Nighttime Recovery Pain Relief No Mess Roll OnMENTHOLChattem, Inc.aa40c907-eeb5-4fda-b35e-439cbecc178c2026-07-31WarningsExact identifier
application number: M017
Alphamale Delay CreamBENZOCAINEProdigy Media Inc53d682ee-0802-a16d-e063-6394a90aeee12026-07-31WarningsExact identifier
application number: M017
Pure Primal Delay CreamBENZOCAINEProdigy Media Inc57e9e894-c14f-d806-e063-6394a90ab8e52026-07-31WarningsExact identifier
application number: M017
SatohapDL-CAMPHOR, L-MENTHOL, METHYL SALICYLATESato Pharmaceutical Co., Ltd.df0e2b83-8f61-4ed8-bcc4-55e4ea7820902026-07-31WarningsExact identifier
application number: M017
SatogesicDL-CAMPHOR, L-MENTHOL, METHYL SALICYLATESato Pharmaceutical Co., Ltd.cb000134-92a4-4304-8ef0-0347190e14142026-07-31WarningsExact identifier
application number: M017
Satogesic HotCAPSAICINSato Pharmaceutical Co., Ltd.16b47cb5-ea5f-4514-9a89-141ee4cc60f82026-07-31WarningsExact identifier
application number: M017
Satohap Cool and Hot PadsCAMPHOR, CAPSAICIN, MENTHOLSato Pharmaceutical Co., Ltd.b6bf1eab-4ab9-f500-e053-2995a90a8d7b2026-07-31Warnings, Adverse reactionsExact identifier
application number: M017
SATOHAP COOL and HOTCAMPHOR, CAPSAICIN, MENTHOLSato Pharmaceuticals Co., Ltd.232a4c76-1a0c-2f4b-e063-6394a90a88492026-07-31Warnings, Adverse reactionsExact identifier
application number: M017
Cortizone 10 Itch Relief Massaging RollerballHYDROCORTISONEChattem, Inc.1e27682c-f856-41f1-9935-37540960a4c72026-07-31WarningsExact identifier
application number: M017
Aspercreme with Lidocaine DryLIDOCAINEChattem, Inc.008abaaa-5e12-4246-a7f5-66f3966acf282026-07-30WarningsExact identifier
application number: M017
ACOLYE Lidocaine Cream Topical Analgesia CreamLIDOCAINE,MENTHOLGuangdong Aimu Biological Technology Co., Ltd57deebf7-52f1-4256-e063-6294a90a75d52026-07-30WarningsExact identifier
application number: M017

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49348-441-72493480441721 TUBE in 1 CARTON (49348-441-72) / 28.4 g in 1 TUBE1 tube1989-10-032026-05-31NoNoCurrent