Anti-itch
- Product NDC
- 53329-091
- 11-digit product format
- 533290091
- Labeler code
- 53329
- Product ID
- 53329-091_40c054e1-8661-4940-e063-6294a90a0200
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- hydrocortisone
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- Medline Industries, LP
- Application
- M017
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2010-03-01
- Substance
- HYDROCORTISONE
- Active strength
- 10 mg/g
- Pharmacologic classes
- Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- 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
- Anti-itch
- Listing expiration
- 2027-12-31
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 |
|---|---|
| b0947381-c0db-4253-ab40-3d45603ae65d | Available on FDA.report |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 53329-091-01 | Anti-itch | 28.4 g in 1 TUBE | CREAM | 28.4 | 13 | |
| 53329-091-01 | Anti-itch | 1 in 1 BOX | CREAM | 1 | 13 | |
| 53329-091-90 | Anti-itch | 1.5 g in 1 PACKET | CREAM | 1.5 | 13 | |
| 53329-091-91 | Anti-itch | 48 in 1 CARTON | CREAM | 48 | 13 | |
| 53329-091-96 | Anti-itch | 144 in 1 CASE | CREAM | 144 | 13 | |
| 53329-091-96 | Anti-itch | 28.4 g in 1 TUBE | CREAM | 28.4 | 13 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 53329-091-01 | GM - Gram | 53329-091 | 9ab0f641-eef6-4977-a15b-abc165bf39b7 | 1 | 2018-08-13 |
DailyMed Socrata Ingredients#
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 |
|---|---|---|---|---|---|---|
| Shopko Hydrocortisone | HYDROCORTISONE | Shopko Stores Operating Co., LLC | 92bcbde3-401a-4301-854e-c352852317d6 | 2025-07-15 | Warnings | M017 |
| TopCare Hydrocortisone | HYDROCORTISONE | Topco Associates LLC | bd3585fa-3b48-49b7-8ad1-749bf1e31ed5 | 2025-07-15 | Warnings | M017 |
| Methyl Salicylate 25% Pain Relieving | METHYL SALICYLATE | Puretek Corporation | 376797ff-cf13-a3c6-e063-6394a90a9de1 | 2025-07-15 | Warnings | M017 |
| TIGER BALM PAIN RELIEVING | CAMPHOR (SYNTHETIC), LEVOMENTHOL, AND CAPSICUM | Haw Par Healthcare Ltd. | 440e97bc-bd97-4733-9955-643b18e7fb18 | 2025-07-15 | Warnings | M017 |
| Tiger Balm Pain Relieving Hydrogel Large | CAMPHOR (SYNTHETIC), LEVOMENTHOL, AND CAPSICUM | Haw Par Healthcare Ltd. | 064d04ca-184d-492b-867c-beaa165ab3e0 | 2025-07-14 | Warnings | M017 |
| Methyl Salicylate 25% Cream | METHYL SALICYLATE | Medcore LLC | 143f76bf-2de4-466a-8a6b-d6ab6314a2c3 | 2025-07-14 | Warnings | M017 |
| BLUESPRING Doctors Pain Formula Pain Relief | MENTHOL | ACA MANAGEMENT LLC | 98f3f719-792f-4a93-95b1-90072e0f8bf4 | 2025-07-14 | Warnings | M017 |
| Shopko Anti-Itch | DIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATE | Shopko Stores Operating Co., LLC | 130119eb-b87e-4a07-8d2a-317369bfa541 | 2025-07-14 | Warnings | M017 |
| Equate Hydrocortisone Intensive Healing Formula | HYDROCORTISONE | Wal-Mart Stores Inc. | 635b49c4-54d2-4b6d-bee8-851fc2c7ca9c | 2025-07-14 | Warnings | M017 |
| ULTRA STRENGTH ZHENG GU SHUI | MENTHOL AND CAMPHOR | GUANGXI YULIN PHARMACEUTICAL GROUP CO LTD | 53397663-044d-4e48-989b-2c6257af5f84 | 2025-07-14 | Warnings, Adverse reactions | M017 |
| TIGER BALM PAIN RELIEVING HYDROGEL | CAMPHOR (SYNTHETIC), LEVOMENTHOL, AND CAPSICUM | Haw Par Healthcare Ltd. | cb60037f-bceb-4090-a5e4-bdda0cbf9f5c | 2025-07-14 | Warnings | M017 |
| Avedana Hydrocortisone Cream with Aloe | HYDROCORTISONE | Unipack LLC | 2a55c426-39b4-4d94-b6b4-6c548c9685e9 | 2025-07-13 | Warnings | M017 |
| Hydrocortisone | HYDROCORTISONE ACETATE | Rite Aid Corporation | cb6e0bed-2ea1-49d2-89e7-2554e7565b74 | 2025-07-11 | Warnings | M017 |
| QUALITY CHOICE Maximum Strength Lidocaine Pain Relief Roll On | LIDOCAINE HYDROCHLORIDE | CHAIN DRUG MARKETING ASSOCIATION | 7b3ff4c1-0b60-4f7a-8aa4-c84b7c7137c4 | 2025-07-11 | Warnings | M017 |
| Antibiotic Plus Pain Relief | NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE | TARGET Corporation | 6fba5890-f48f-4302-a8ac-5087a6e03bd5 | 2025-07-11 | Warnings | M017 |
| TopCare Antibiotic Plus Pain Relief | NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE | Topco Associates LLC | 55dc4025-f07f-41b2-8b18-6a11ee04b5cc | 2025-07-11 | Warnings | M017 |
| Benadryl Extra Strength Itch Relief | DIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATE | Kenvue Brands LLC | 309d9be0-e367-429a-a1fa-ab7855477c8a | 2025-07-10 | Warnings | M017 |
| Bengay Vanishing Scent | MENTHOL, UNSPECIFIED FORM | Kenvue Brands LLC | 6cc3294b-3b0f-44d0-af71-61db1022d269 | 2025-07-10 | Warnings | M017 |
| Cold Hot Medicated Patch 5% Menthol | MENTHOL | Quality Choice | ce544a7c-8dc6-4e63-b499-d8a4e0ec48c3 | 2025-07-10 | Warnings | M017 |
| Hydrocortisone | HYDROCORTISONE ACETATE | Walgreen Company | bff322f1-59c3-41e0-8685-fcfe52bf4b42 | 2025-07-10 | Warnings | M017 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 106258 | hydrocortisone 1 % Topical Cream | PSN | b0947381-c0db-4253-ab40-3d45603ae65d | 13 |
| 106258 | hydrocortisone 10 MG/ML Topical Cream | SCD | b0947381-c0db-4253-ab40-3d45603ae65d | 13 |
| 106258 | hydrocortisone 1 % (as hydrocortisone acetate 1.2 % ) Topical Cream | SY | b0947381-c0db-4253-ab40-3d45603ae65d | 13 |
| 106258 | hydrocortisone 1 % Topical Cream | SY | b0947381-c0db-4253-ab40-3d45603ae65d | 13 |
| 106258 | hydrocortisone 1 GM per 100 GM Topical Cream | SY | b0947381-c0db-4253-ab40-3d45603ae65d | 13 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 53329-091-01 | 53329009101 | 1 TUBE in 1 BOX (53329-091-01) / 28.4 g in 1 TUBE | 1 tube | 2010-03-01 | 0000-00-00 | No | No | Current |
| 53329-091-90 | 53329009190 | 1.5 g in 1 PACKET (53329-091-90) | 1.5 g | 2010-03-01 | 0000-00-00 | No | No | Current |
| 53329-091-91 | 53329009191 | 48 PACKET in 1 CARTON (53329-091-91) / 1.5 g in 1 PACKET (53329-091-90) | 48 packet | 2010-03-01 | 0000-00-00 | No | No | Current |
| 53329-091-96 | 53329009196 | 144 TUBE in 1 CASE (53329-091-96) / 28.4 g in 1 TUBE | 144 tube | 2010-03-01 | 0000-00-00 | No | No | Current |