Home NDC 0472-0339-56 Hydrocortisone with Aloe
Product NDC 0472-0339
Requested package NDC 0472-0339-56
11-digit product format 004720339
Labeler code 0472
Product ID 0472-0339_f08adb32-103c-4972-8ede-741bd7765e7b
Type HUMAN OTC DRUG
Nonproprietary name Hydrocortisone
Dosage form CREAM
Route TOPICAL
Labeler Actavis Pharma, Inc.
Application part348
Marketing category OTC MONOGRAPH NOT FINAL
Marketing start 1997-09-01
Marketing end 2022-11-30
Substance HYDROCORTISONE
Active strength 1 g/100g
Pharmacologic classes Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag No
Listing certified through 0000-00-00
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 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded HYDROCORTISONE ACTIVE INGREDIENT WI4X0X7BPJ HYDROCORTISONE MAXIMUM STRENGTH (HYDROCORTISONE) CREAM [PREFERRED PHARMACEUTICALS, INC.] 2 HYDROCORTISONE ACTIVE INGREDIENT WI4X0X7BPJ HYDROCORTISONE WITH ALOE MAXIMUM STRENGTH (HYDROCORTISONE) CREAM [ACTAVIS MID ATLANTIC LLC] 2 HYDROCORTISONE ACTIVE MOIETY WI4X0X7BPJ HYDROCORTISONE MAXIMUM STRENGTH (HYDROCORTISONE) CREAM [PREFERRED PHARMACEUTICALS, INC.] 2 HYDROCORTISONE ACTIVE MOIETY WI4X0X7BPJ HYDROCORTISONE WITH ALOE MAXIMUM STRENGTH (HYDROCORTISONE) CREAM [ACTAVIS MID ATLANTIC LLC] 2 ALOE VERA LEAF INACTIVE INGREDIENT ZY81Z83H0X HYDROCORTISONE WITH ALOE MAXIMUM STRENGTH (HYDROCORTISONE) CREAM [ACTAVIS MID ATLANTIC LLC] 2 ALOE VERA LEAF INACTIVE INGREDIENT ZY81Z83H0X HYDROCORTISONE MAXIMUM STRENGTH (HYDROCORTISONE) CREAM [PREFERRED PHARMACEUTICALS, INC.] 2 CETYL ALCOHOL INACTIVE INGREDIENT 936JST6JCN HYDROCORTISONE MAXIMUM STRENGTH (HYDROCORTISONE) CREAM [PREFERRED PHARMACEUTICALS, INC.] 2 CETYL ALCOHOL INACTIVE INGREDIENT 936JST6JCN HYDROCORTISONE WITH ALOE MAXIMUM STRENGTH (HYDROCORTISONE) CREAM [ACTAVIS MID ATLANTIC LLC] 2 CITRIC ACID MONOHYDRATE INACTIVE INGREDIENT 2968PHW8QP HYDROCORTISONE WITH ALOE MAXIMUM STRENGTH (HYDROCORTISONE) CREAM [ACTAVIS MID ATLANTIC LLC] 2 CITRIC ACID MONOHYDRATE INACTIVE INGREDIENT 2968PHW8QP HYDROCORTISONE MAXIMUM STRENGTH (HYDROCORTISONE) CREAM [PREFERRED PHARMACEUTICALS, INC.] 2 GLYCERYL MONOSTEARATE INACTIVE INGREDIENT 230OU9XXE4 HYDROCORTISONE WITH ALOE MAXIMUM STRENGTH (HYDROCORTISONE) CREAM [ACTAVIS MID ATLANTIC LLC] 2 GLYCERYL MONOSTEARATE INACTIVE INGREDIENT 230OU9XXE4 HYDROCORTISONE MAXIMUM STRENGTH (HYDROCORTISONE) CREAM [PREFERRED PHARMACEUTICALS, INC.] 2 ISOPROPYL MYRISTATE INACTIVE INGREDIENT 0RE8K4LNJS HYDROCORTISONE MAXIMUM STRENGTH (HYDROCORTISONE) CREAM [PREFERRED PHARMACEUTICALS, INC.] 2 ISOPROPYL MYRISTATE INACTIVE INGREDIENT 0RE8K4LNJS HYDROCORTISONE WITH ALOE MAXIMUM STRENGTH (HYDROCORTISONE) CREAM [ACTAVIS MID ATLANTIC LLC] 2 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T HYDROCORTISONE WITH ALOE MAXIMUM STRENGTH (HYDROCORTISONE) CREAM [ACTAVIS MID ATLANTIC LLC] 2 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T HYDROCORTISONE MAXIMUM STRENGTH (HYDROCORTISONE) CREAM [PREFERRED PHARMACEUTICALS, INC.] 2 POLYOXYL 40 STEARATE INACTIVE INGREDIENT 13A4J4NH9I HYDROCORTISONE MAXIMUM STRENGTH (HYDROCORTISONE) CREAM [PREFERRED PHARMACEUTICALS, INC.] 2 POLYOXYL 40 STEARATE INACTIVE INGREDIENT 13A4J4NH9I HYDROCORTISONE WITH ALOE MAXIMUM STRENGTH (HYDROCORTISONE) CREAM [ACTAVIS MID ATLANTIC LLC] 2 POLYSORBATE 60 INACTIVE INGREDIENT CAL22UVI4M HYDROCORTISONE MAXIMUM STRENGTH (HYDROCORTISONE) CREAM [PREFERRED PHARMACEUTICALS, INC.] 2 POLYSORBATE 60 INACTIVE INGREDIENT CAL22UVI4M HYDROCORTISONE WITH ALOE MAXIMUM STRENGTH (HYDROCORTISONE) CREAM [ACTAVIS MID ATLANTIC LLC] 2 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 HYDROCORTISONE MAXIMUM STRENGTH (HYDROCORTISONE) CREAM [PREFERRED PHARMACEUTICALS, INC.] 2 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 HYDROCORTISONE WITH ALOE MAXIMUM STRENGTH (HYDROCORTISONE) CREAM [ACTAVIS MID ATLANTIC LLC] 2 PROPYLPARABEN INACTIVE INGREDIENT Z8IX2SC1OH HYDROCORTISONE WITH ALOE MAXIMUM STRENGTH (HYDROCORTISONE) CREAM [ACTAVIS MID ATLANTIC LLC] 2 PROPYLPARABEN INACTIVE INGREDIENT Z8IX2SC1OH HYDROCORTISONE MAXIMUM STRENGTH (HYDROCORTISONE) CREAM [PREFERRED PHARMACEUTICALS, INC.] 2 SODIUM CITRATE INACTIVE INGREDIENT 1Q73Q2JULR HYDROCORTISONE WITH ALOE MAXIMUM STRENGTH (HYDROCORTISONE) CREAM [ACTAVIS MID ATLANTIC LLC] 2 SODIUM CITRATE INACTIVE INGREDIENT 1Q73Q2JULR HYDROCORTISONE MAXIMUM STRENGTH (HYDROCORTISONE) CREAM [PREFERRED PHARMACEUTICALS, INC.] 2 SORBIC ACID INACTIVE INGREDIENT X045WJ989B HYDROCORTISONE MAXIMUM STRENGTH (HYDROCORTISONE) CREAM [PREFERRED PHARMACEUTICALS, INC.] 2 SORBIC ACID INACTIVE INGREDIENT X045WJ989B HYDROCORTISONE WITH ALOE MAXIMUM STRENGTH (HYDROCORTISONE) CREAM [ACTAVIS MID ATLANTIC LLC] 2 SORBITAN MONOSTEARATE INACTIVE INGREDIENT NVZ4I0H58X HYDROCORTISONE MAXIMUM STRENGTH (HYDROCORTISONE) CREAM [PREFERRED PHARMACEUTICALS, INC.] 2 SORBITAN MONOSTEARATE INACTIVE INGREDIENT NVZ4I0H58X HYDROCORTISONE WITH ALOE MAXIMUM STRENGTH (HYDROCORTISONE) CREAM [ACTAVIS MID ATLANTIC LLC] 2 STEARYL ALCOHOL INACTIVE INGREDIENT 2KR89I4H1Y HYDROCORTISONE WITH ALOE MAXIMUM STRENGTH (HYDROCORTISONE) CREAM [ACTAVIS MID ATLANTIC LLC] 2 STEARYL ALCOHOL INACTIVE INGREDIENT 2KR89I4H1Y HYDROCORTISONE MAXIMUM STRENGTH (HYDROCORTISONE) CREAM [PREFERRED PHARMACEUTICALS, INC.] 2 WATER INACTIVE INGREDIENT 059QF0KO0R HYDROCORTISONE MAXIMUM STRENGTH (HYDROCORTISONE) CREAM [PREFERRED PHARMACEUTICALS, INC.] 2 WATER INACTIVE INGREDIENT 059QF0KO0R HYDROCORTISONE WITH ALOE MAXIMUM STRENGTH (HYDROCORTISONE) CREAM [ACTAVIS MID ATLANTIC LLC] 2 WHITE WAX INACTIVE INGREDIENT 7G1J5DA97F HYDROCORTISONE MAXIMUM STRENGTH (HYDROCORTISONE) CREAM [PREFERRED PHARMACEUTICALS, INC.] 2 WHITE WAX INACTIVE INGREDIENT 7G1J5DA97F HYDROCORTISONE WITH ALOE MAXIMUM STRENGTH (HYDROCORTISONE) CREAM [ACTAVIS MID ATLANTIC LLC] 2
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0472-0339-56 00472033956 1 TUBE in 1 CARTON (0472-0339-56) > 28 g in 1 TUBE 1 tube 1997-09-01 2022-11-30 No No Current