Hydrocortisone with aloe

Product NDC
13709-317
11-digit product format
137090317
Labeler code
13709
Product ID
13709-317_1ce25285-5f43-da63-e063-6394a90ab690
Type
HUMAN OTC DRUG
Nonproprietary name
hydrocortisone with Aloe Anti Itch
Dosage form
CREAM
Route
TOPICAL
Labeler
NeilMed Pharmaceuticals Inc.
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-08-18
Substance
HYDROCORTISONE
Active strength
10.2 mg/g
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Hydrocortisone with aloe
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HYDROCORTISONE10.2 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiWI4X0X7BPJ

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
15bd4439-874a-4934-9954-248e5455d460Product name120260310
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56bb0587-1bf2-48b2-9d93-fc9f59d1eeb2Product name120250325
4d56e8eb-d741-d4a5-de3f-2bab1af75a60Product name720220608
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
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
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61e59a42-186b-9f4b-aec3-fb49a6debc31Product name120140508
705740e1-dee5-2610-c5a3-4c59cd9d62afProduct name120140508
7bdc4804-3832-c0df-e519-72b6d47c9792Product name120140508
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fe21f3fd-a378-0654-1972-db3c3b64470eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
13709-317-01Hydrocortisone with aloe28 g in 1 TUBECREAM284
13709-317-01Hydrocortisone with aloe1 in 1 CARTONCREAM14
13709-317-02Hydrocortisone with aloe1 in 1 CARTONCREAM14
13709-317-02Hydrocortisone with aloe56 g in 1 TUBECREAM564

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
13709-317HYDROCORTISONE WITH ALOE (HYDROCORTISONE WITH ALOE ANTI ITCH) CREAM [NEILMED PHARMACEUTICALS INC.]4Current NDC, 4 package rows20240711_032b9f58-5f64-04dd-e063-6294a90a6bb9.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
13709-317-01137090317011 TUBE in 1 CARTON (13709-317-01) / 28 g in 1 TUBE1 tube2023-08-18NoNoCurrent
13709-317-02137090317021 TUBE in 1 CARTON (13709-317-02) / 56 g in 1 TUBE1 tube2023-08-18NoNoCurrent