Bioelements
- Product NDC
- 49825-126
- 11-digit product format
- 498250126
- Labeler code
- 49825
- Product ID
- 49825-126_0afc9d3f-47f9-4424-8ad4-2b4b7d34607f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Hydrocortisone Acetate
- Dosage form
- LOTION
- Route
- TOPICAL
- Labeler
- Bioelements, Inc.
- Application
- part348
- Marketing category
- OTC MONOGRAPH NOT FINAL
- Marketing start
- 2012-08-23
- Marketing end
- 0000-00-00
- Substance
- HYDROCORTISONE ACETATE
- Active strength
- 0 mL/88mL
- Pharmacologic classes
- Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
- NDC exclude flag
- E
- Listing certified through
- 2018-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 49825-126-01 | Immediate ComfortBioelements | 88 mL in 1 BOTTLE | LOTION | 88 | | 2 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| HYDROCORTISONE ACETATE | ACTIVE INGREDIENT | 3X7931PO74 | BIOELEMENTS IMMEDIATE COMFORT (HYDROCORTISONE ACETATE) LOTION [BIOELEMENTS, INC.] | 2 | |
| HYDROCORTISONE | ACTIVE MOIETY | WI4X0X7BPJ | BIOELEMENTS IMMEDIATE COMFORT (HYDROCORTISONE ACETATE) LOTION [BIOELEMENTS, INC.] | 2 | |
| .ALPHA.-TOCOPHEROL ACETATE | INACTIVE INGREDIENT | 9E8X80D2L0 | BIOELEMENTS IMMEDIATE COMFORT (HYDROCORTISONE ACETATE) LOTION [BIOELEMENTS, INC.] | 2 | |
| ALKYL (C12-15) BENZOATE | INACTIVE INGREDIENT | A9EJ3J61HQ | BIOELEMENTS IMMEDIATE COMFORT (HYDROCORTISONE ACETATE) LOTION [BIOELEMENTS, INC.] | 2 | |
| BUTYLENE GLYCOL | INACTIVE INGREDIENT | 3XUS85K0RA | BIOELEMENTS IMMEDIATE COMFORT (HYDROCORTISONE ACETATE) LOTION [BIOELEMENTS, INC.] | 2 | |
| CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) | INACTIVE INGREDIENT | 4Q93RCW27E | BIOELEMENTS IMMEDIATE COMFORT (HYDROCORTISONE ACETATE) LOTION [BIOELEMENTS, INC.] | 2 | |
| GLYCERYL MONOSTEARATE | INACTIVE INGREDIENT | 230OU9XXE4 | BIOELEMENTS IMMEDIATE COMFORT (HYDROCORTISONE ACETATE) LOTION [BIOELEMENTS, INC.] | 2 | |
| METHYLISOTHIAZOLINONE | INACTIVE INGREDIENT | 229D0E1QFA | BIOELEMENTS IMMEDIATE COMFORT (HYDROCORTISONE ACETATE) LOTION [BIOELEMENTS, INC.] | 2 | |
| PEG-100 STEARATE | INACTIVE INGREDIENT | YD01N1999R | BIOELEMENTS IMMEDIATE COMFORT (HYDROCORTISONE ACETATE) LOTION [BIOELEMENTS, INC.] | 2 | |
| PHENOXYETHANOL | INACTIVE INGREDIENT | HIE492ZZ3T | BIOELEMENTS IMMEDIATE COMFORT (HYDROCORTISONE ACETATE) LOTION [BIOELEMENTS, INC.] | 2 | |
| POLYSORBATE 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | BIOELEMENTS IMMEDIATE COMFORT (HYDROCORTISONE ACETATE) LOTION [BIOELEMENTS, INC.] | 2 | |
| SODIUM HYDROXIDE | INACTIVE INGREDIENT | 55X04QC32I | BIOELEMENTS IMMEDIATE COMFORT (HYDROCORTISONE ACETATE) LOTION [BIOELEMENTS, INC.] | 2 | |
| SORBITOL | INACTIVE INGREDIENT | 506T60A25R | BIOELEMENTS IMMEDIATE COMFORT (HYDROCORTISONE ACETATE) LOTION [BIOELEMENTS, INC.] | 2 | |
| SUNFLOWER OIL | INACTIVE INGREDIENT | 3W1JG795YI | BIOELEMENTS IMMEDIATE COMFORT (HYDROCORTISONE ACETATE) LOTION [BIOELEMENTS, INC.] | 2 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | BIOELEMENTS IMMEDIATE COMFORT (HYDROCORTISONE ACETATE) LOTION [BIOELEMENTS, INC.] | 2 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 49825-126 | BIOELEMENTS IMMEDIATE COMFORT (HYDROCORTISONE ACETATE) LOTION [BIOELEMENTS, INC.] | 2 | Legacy NDC, 1 package rows | 20120828_4c561849-e91b-4790-b6e7-8222e22df5f9.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Status |
|---|
| 49825-126-01 | 49825012601 | 88 mL in 1 BOTTLE | 88 ml | Historical |