SionBiotext Hydrocortisone
- Product NDC
- 68786-001
- 11-digit product format
- 687860001
- Labeler code
- 68786
- Product ID
- 68786-001_35074279-3e3d-2a74-e063-6294a90af26f
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Hydrocortisone Acetate 1%
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- Sion Biotext Medical Ltd
- Application
- M017
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2025-05-13
- Substance
- HYDROCORTISONE ACETATE
- Active strength
- .1 g/g
- Pharmacologic classes
- Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- SionBiotext Hydrocortisone
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| HYDROCORTISONE ACETATE | .1 g/g |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 3X7931PO74 | Internal UNII lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 35073eae-26fe-2bb5-e063-6294a90ab56a | Available on FDA.report |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 68786-001-28 | SionBiotext Hydrocortisone | 28.3 g in 1 BOX | CREAM | 28.3 | 1 |
DailyMed Dashboard NDC Coverage#
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Salonpas DEEP Relieving | CAMPHOR, MENTHOL, METHYL SALICYLATE | Hisamitsu America, Inc. | a4ddb2b9-d023-4c8c-9285-93d51f93207d | 2024-12-03 | Warnings | M017 |
| Salonpas LIDOCAINE PLUS | BENZYL ALCOHOL, LIDOCAINE HYDROCHLORIDE | Hisamitsu America, Inc. | ea5b4a7f-d47d-4dbd-9288-c01329e387e5 | 2024-12-03 | Warnings | M017 |
| Hempvana Ultra Strength Pain Relief - Overnight | LIDOCAINE | Telebrands Corp | 1030d478-6805-6579-e063-6294a90a0c76 | 2024-12-02 | Warnings | M017 |
| Campho-Phenique Cold Sore Treatment | CAMPHOR (SYNTHETIC) AND PHENOL | Foundation Consumer Healthcare LLC | 106c0bb2-f2e2-4255-867d-d09ff6a5a2e6 | 2024-12-02 | Warnings | M017 |
| Campho-Phenique Antiseptic | CAMPHOR (SYNTHETIC) AND PHENOL | Foundation Consumer Healthcare LLC | 82edaef0-0709-4ae1-a664-c9c5adb91ee1 | 2024-12-02 | Warnings | M017 |
| Thermacare Arthritis and Nerve Pain Therapy Capsaicin Roll On | THERMACARE CAPSAICIN ROLL ON | Clarion Brands LLC | 2850f7e7-41dd-f5f9-e063-6394a90ae519 | 2024-12-02 | Warnings | M017 |
| BURN | LIDOCAINE HYDROCHLORIDE, BENZALKONIUM CHLORIDE | NINGBO TIANBO FIRST AID PRODUCT CO., LTD. | 2ec1cf79-c341-4b79-9047-ce29f0dff419 | 2024-11-29 | Warnings | M017 |
| TheraCare Pain Relieving Lidocaine Cream | LIDOCAINE HYDROCHLORIDE | Veridian Healthcare | 242204d3-efc7-f7a9-e063-6294a90a5af1 | 2024-11-27 | Warnings | M017 |
| Walgreens Flexible Pain Relieving Lidocaine | LIDOCAINE, MENTHOL | Walgreen Co. | 6f070fa3-a61a-4523-a470-ab58bf9400a3 | 2024-11-27 | Warnings | M017 |
| Benadryl Original Strength Itch Stopping | DIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATE | Kenvue Brands LLC | 920c50cb-9bdd-4a36-bb3d-c2559db73327 | 2024-11-26 | Warnings | M017 |
| Universal ARTHRITIS and SPORT | METHYL SALICYLATE, CAPSICUM | Universal Distribution Center LLC | 884907a8-c884-4cce-ac10-9d4848fdba3e | 2024-11-22 | Warnings | M017 |
| Universal ARTHRITIS and SPORT | METHYL SALICYLATE, CAPSICUM | Universal Distribution Center LLC | 7f067e95-e01c-4b9a-a02e-0af097beb18c | 2024-11-22 | Warnings | M017 |
| Universal ARTHRITIS and SPORT | METHYL SALICYLATE, CAPSICUM | Universal Distribution Center LLC | 9ece9b3a-0092-4c1c-a913-c2fefcd70541 | 2024-11-22 | Warnings | M017 |
| Sting Relief Pad | BENZOCAINE, ISOPROPYL ALCOHOL | Changzhou Maokang Medical Products Co., Ltd | 1936c5f4-274b-8e49-e063-6394a90ac642 | 2024-11-21 | Warnings | M017 |
| Hempvana Ultra Strength Pain Relief Cream Platinum 4% Lidocaine | LIDOCAINE 4% | Telebrands Corp | 2788189e-35bc-d48c-e063-6294a90ae6c2 | 2024-11-21 | Warnings | M017 |
| Family Wellness Ultra Strength Muscle Rub | ULTRA STRENGTH MUSCLE RUB | FAMILY DOLLAR (Family Wellness) | 554c7d3c-09f4-4923-b4ca-d5de8f7e2c9a | 2024-11-21 | Warnings | M017 |
| Family Wellness Anorectal Lidocaine | ANORECTAL LIDOCAINE | FAMILY DOLLAR (Family Wellness) | ed7e0cdc-ca4b-47ba-b82b-49fb4913ef8d | 2024-11-21 | Warnings | M017 |
| Family Wellness Hot and Cold Pain Relief | HOT AND COLD PAIN RELIEF | FAMILY DOLLAR (Family Wellness) | b70e343b-18aa-4e45-ae8e-79d8c84ad205 | 2024-11-21 | Warnings | M017 |
| Signature Care Lidocaine Cream | LIDOCAINE | Better Living Brands LLC | 5483729e-ef1a-47a2-b7cf-c19744f52073 | 2024-11-21 | Warnings | M017 |
| WINCO Hydrocortisone | HYDROCORTISONE 1% | WinCo Foods LLC | 26a29de3-4b79-4a3a-93b6-a14c5e91a8c6 | 2024-11-21 | Warnings | M017 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 68786-001-28 | 68786000128 | 28.3 g in 1 BOX (68786-001-28) | 28.3 g | 2025-05-13 | No | No | Current |