Home NDC 49825-134 Immediate Comfort
Product NDC 49825-134
11-digit product format 498250134
Labeler code 49825
Product ID 49825-134_2f599a6d-1d8e-4325-b851-f1c2badaff1d
Type HUMAN OTC 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 1 g/88mL
NDC exclude flag No
Listing certified through 2020-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 24 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 49825-134-01 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 49825-134-01 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 49825-134-01 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 49825-134-01 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 49825-134-01 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 49825-134-01 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 49825-134-01 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 49825-134-01 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 49825-134-01 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 49825-134-01 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 49825-134-01 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 49825-134-01 557ba5c1ecfa…9c80585c8c6e…
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded HYDROCORTISONE ACETATE ACTIVE INGREDIENT 3X7931PO74 IMMEDIATE COMFORT BIOELEMENTS (HYDROCORTISONE ACETATE) LOTION [BIOELEMENTS, INC.] 3 HYDROCORTISONE ACTIVE MOIETY WI4X0X7BPJ IMMEDIATE COMFORT BIOELEMENTS (HYDROCORTISONE ACETATE) LOTION [BIOELEMENTS, INC.] 3 .ALPHA.-TOCOPHEROL ACETATE INACTIVE INGREDIENT 9E8X80D2L0 IMMEDIATE COMFORT BIOELEMENTS (HYDROCORTISONE ACETATE) LOTION [BIOELEMENTS, INC.] 3 ALKYL (C12-15) BENZOATE INACTIVE INGREDIENT A9EJ3J61HQ IMMEDIATE COMFORT BIOELEMENTS (HYDROCORTISONE ACETATE) LOTION [BIOELEMENTS, INC.] 3 BUTYLENE GLYCOL INACTIVE INGREDIENT 3XUS85K0RA IMMEDIATE COMFORT BIOELEMENTS (HYDROCORTISONE ACETATE) LOTION [BIOELEMENTS, INC.] 3 CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) INACTIVE INGREDIENT 4Q93RCW27E IMMEDIATE COMFORT BIOELEMENTS (HYDROCORTISONE ACETATE) LOTION [BIOELEMENTS, INC.] 3 GLYCERYL MONOSTEARATE INACTIVE INGREDIENT 230OU9XXE4 IMMEDIATE COMFORT BIOELEMENTS (HYDROCORTISONE ACETATE) LOTION [BIOELEMENTS, INC.] 3 METHYLISOTHIAZOLINONE INACTIVE INGREDIENT 229D0E1QFA IMMEDIATE COMFORT BIOELEMENTS (HYDROCORTISONE ACETATE) LOTION [BIOELEMENTS, INC.] 3 PEG-100 STEARATE INACTIVE INGREDIENT YD01N1999R IMMEDIATE COMFORT BIOELEMENTS (HYDROCORTISONE ACETATE) LOTION [BIOELEMENTS, INC.] 3 PHENOXYETHANOL INACTIVE INGREDIENT HIE492ZZ3T IMMEDIATE COMFORT BIOELEMENTS (HYDROCORTISONE ACETATE) LOTION [BIOELEMENTS, INC.] 3 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H IMMEDIATE COMFORT BIOELEMENTS (HYDROCORTISONE ACETATE) LOTION [BIOELEMENTS, INC.] 3 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I IMMEDIATE COMFORT BIOELEMENTS (HYDROCORTISONE ACETATE) LOTION [BIOELEMENTS, INC.] 3 SORBITOL INACTIVE INGREDIENT 506T60A25R IMMEDIATE COMFORT BIOELEMENTS (HYDROCORTISONE ACETATE) LOTION [BIOELEMENTS, INC.] 3 SUNFLOWER OIL INACTIVE INGREDIENT 3W1JG795YI IMMEDIATE COMFORT BIOELEMENTS (HYDROCORTISONE ACETATE) LOTION [BIOELEMENTS, INC.] 3 WATER INACTIVE INGREDIENT 059QF0KO0R IMMEDIATE COMFORT BIOELEMENTS (HYDROCORTISONE ACETATE) LOTION [BIOELEMENTS, INC.] 3
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 49825-134-01 49825013401 88 mL in 1 BOTTLE (49825-134-01) 88 ml 2012-08-23 0000-00-00 No No Current