Family Wellness Max Strength 1 Hydrocortisone Cream
- Product NDC
- 55319-982
- 11-digit product format
- 553190982
- Labeler code
- 55319
- Product ID
- 55319-982_2ef25770-9cba-cbd8-e063-6394a90ac9df
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- HYDROCORTISONE
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- Family Dollar Stores, Inc
- Application
- M017
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2024-01-01
- Substance
- HYDROCORTISONE
- Active strength
- 10 mg/g
- Pharmacologic classes
- Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
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.
| Captured / source date | Dataset | Scope | Package NDC | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|
| 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 | 55319-982-00 | 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 | 55319-982-00 | 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 | 55319-982-00 | 0efc9e666f02… | f202fb6c5f17… |
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
- Family Wellness Max Strength 1 Hydrocortisone Cream
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| HYDROCORTISONE | 10 mg/g |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| WI4X0X7BPJ | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 106258 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| bca5ac2c-45cd-44e3-98f1-317a04e44d7d | Available on FDA.report |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 55319-982-00 | 2025-02-07 | C162847 | 48780-1 | 2cef2736-7440-d83d-e063-dadaa90ab31f | Family Wellness Max Strength 1% Hydrocortisone Cream |
| 55319-982-00 | 2025-01-30 | C162847 | 48780-1 | 2cef2736-7440-d83d-e063-dadaa90ab31f | Family Wellness Max Strength 1% Hydrocortisone Cream |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 55319-982-00 | Family Wellness Max Strength 1 Hydrocortisone Cream | 1 in 1 BOX | CREAM | 1 | 3 | |
| 55319-982-00 | Family Wellness Max Strength 1 Hydrocortisone Cream | 28 g in 1 TUBE | CREAM | 28 | 3 |
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 |
|---|---|---|---|---|---|---|
| Bactine Max Lidocaine Roll-on 2.5oz | LIDOCAINE | WellSpring Pharmaceutical Corporation | 09b32a98-9131-451e-87a6-81a1e4ed7ec5 | 2023-04-25 | Warnings | M017 |
| Icy Hot Pro Dry | CAMPHOR, MENTHOL | Chattem, Inc. | 4de1bc29-d166-4599-9e75-5f841bf20967 | 2023-03-01 | Warnings | M017 |
| Icy Hot Vanishing Scent | MENTHOL | Chattem, Inc. | e2092016-9741-433d-92e6-74bfddadb72c | 2022-09-29 | Warnings | M017 |
| New Terocin | METHYL SALICYLATE, CAPSAICIN, AND MENTHOL | Alexso, Inc | 5dbd5fc0-a27e-4979-aca7-28f73096fd5f | 2022-08-18 | Warnings | M017 |
| FIRSTAR Sting Relief Pad | BENZOCAINE | JIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD. | 0e491a7a-4204-439f-862d-741cbc0be9fd | 2021-07-06 | Warnings | M017 |
| Arthritis Relief GoodSense | TROLAMINE SALICYLATE | Geiss, Destin & Dunn, Inc | a253730a-2187-07de-e053-2a95a90a9877 | 2020-04-02 | Warnings | M017 |
| Aloe Cort | HYDROCORTISONE | Topiderm, Inc. | 789a6669-3320-4558-8d6f-ab255db50d8d | 2019-09-17 | Warnings | M017 |
| Eagle Brand Medicated Roll On Refresh | CAMPHOR, MENTHOL | Borden Company (Private) Limited | 567b6820-fb52-630e-e063-6294a90a8bf8 | 2015-07-01 | Warnings | M017 |
| Eagle Brand Medicated Oil Aromatic | CAMPHOR, MENTHOL, METHYL SALICYLATE | Borden Company (Private) Limited | 54e45d89-e8c3-6fc3-e063-6394a90aac4e | 2015-06-15 | Warnings | M017 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 106258 | hydrocortisone 1 % Topical Cream | PSN | bca5ac2c-45cd-44e3-98f1-317a04e44d7d | 3 |
| 106258 | hydrocortisone 10 MG/ML Topical Cream | SCD | bca5ac2c-45cd-44e3-98f1-317a04e44d7d | 3 |
| 106258 | hydrocortisone 1 % (as hydrocortisone acetate 1.2 % ) Topical Cream | SY | bca5ac2c-45cd-44e3-98f1-317a04e44d7d | 3 |
| 106258 | hydrocortisone 1 % Topical Cream | SY | bca5ac2c-45cd-44e3-98f1-317a04e44d7d | 3 |
| 106258 | hydrocortisone 1 GM per 100 GM Topical Cream | SY | bca5ac2c-45cd-44e3-98f1-317a04e44d7d | 3 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 55319-982-00 | 55319098200 | 1 TUBE in 1 BOX (55319-982-00) / 28 g in 1 TUBE | 1 tube | 2024-01-01 | No | No | Current |