NDC 49825-126

Bioelements Immediate Comfort

Hydrocortisone Acetate

Bioelements Immediate Comfort is a Topical Lotion in the Human Prescription Drug category. It is labeled and distributed by Bioelements, Inc.. The primary component is Hydrocortisone Acetate.

• Product ID: 49825-126_0afc9d3f-47f9-4424-8ad4-2b4b7d34607f
• NDC: 49825-126
• Product Type: Human Prescription Drug
• Proprietary Name: Bioelements Immediate Comfort
• Generic Name: Hydrocortisone Acetate
• Dosage Form: Lotion
• Route of Administration: TOPICAL
• Marketing Start Date: 2012-08-23
• Marketing Category: OTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
• Application Number: part348
• Labeler Name: Bioelements, Inc.
• Substance Name: HYDROCORTISONE ACETATE
• Active Ingredient Strength: 0 mL/88mL
• Pharm Classes: Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
• NDC Exclude Flag: E
• Listing Certified Through: 2018-12-31

Packaging

NDC 49825-126-01

88 mL in 1 BOTTLE (49825-126-01)

• Marketing Start Date: 2012-08-23
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 49825-126-01 [49825012601]

Immediate Comfort Immediate Comfort LOTION

• Marketing Category: OTC monograph not final
• Application Number: part348
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2012-08-23
• Inactivation Date: 2020-01-31

Drug Details

Active Ingredients

Ingredient	Strength
HYDROCORTISONE ACETATE	.088 mL/88mL

OpenFDA Data

• SPL SET ID: 4c561849-e91b-4790-b6e7-8222e22df5f9
• Manufacturer:
  • Bioelements, Inc.
• UNII:
  • 3X7931PO74
• RxNorm Concept Unique ID - RxCUI:
  • 1441185
• UPC Code:
  • 0836490001513

Pharmacological Class

• Corticosteroid [EPC]
• Corticosteroid Hormone Receptor Agonists [MoA]

NDC Crossover Matching brand name "Bioelements Immediate Comfort" or generic name "Hydrocortisone Acetate"

NDC	Brand Name	Generic Name
49825-126	Bioelements Immediate Comfort	Bioelements Immediate Comfort
0316-0140	Ala Scalp	Hydrocortisone Acetate
0713-0503	ANUCORT-HC	Hydrocortisone Acetate
43474-000	bioCorneum HC Advanced Scar Supervision Anti-Itch	HYDROCORTISONE ACETATE
0037-6830	Cortifoam	hydrocortisone acetate
16477-201	Hemmorex-HC	hydrocortisone acetate
16477-202	Hemmorex-HC	hydrocortisone acetate
0363-0972	Hydrocortisone	Hydrocortisone Acetate
11822-2069	Hydrocortisone	Hydrocortisone Acetate
0574-7090	Hydrocortisone Acetate	HYDROCORTISONE ACETATE
0574-7093	Hydrocortisone Acetate	HYDROCORTISONE ACETATE
0713-0493	Hydrocortisone Acetate	HYDROCORTISONE ACETATE
10135-751	Hydrocortisone Acetate	Hydrocortisone Acetate
16571-676	Hydrocortisone Acetate	Hydrocortisone Acetate
24689-102	Hydrocortisone Acetate	Hydrocortisone Acetate
24689-103	Hydrocortisone Acetate	Hydrocortisone Acetate
39328-029	Hydrocortisone Acetate	Hydrocortisone Acetate
39328-129	Hydrocortisone Acetate	Hydrocortisone Acetate
42494-301	Hydrocortisone Acetate	HYDROCORTISONE ACETATE
42494-302	Hydrocortisone Acetate	HYDROCORTISONE ACETATE
42494-341	Hydrocortisone Acetate	Hydrocortisone Acetate
42494-342	Hydrocortisone Acetate	Hydrocortisone Acetate
47832-205	Hydrocortisone Acetate	Hydrocortisone Acetate
0179-8710	KAISER PERMANENTE	Hydrocortisone acetate
47682-923	Medi-First 1% Hydrocortisone	Hydrocortisone acetate
47682-207	Medi-First Hydrocortisone 1%	Hydrocortisone acetate
15014-185	NuCort	Hydrocortisone Acetate
11509-5101	Vagisil Anti-Itch Creme Maximum Strength Sensitive Skin Formula	Hydrocortisone Acetate