ITCH X
- Product NDC
- 0225-0495
- 11-digit product format
- 002250495
- Labeler code
- 0225
- Product ID
- 0225-0495_2888be26-0ebc-ab78-e063-6394a90ada63
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- BENZYL ALCOHOL/PRAMOXINE HYDROCHLORIDE
- Dosage form
- GEL
- Route
- TOPICAL
- Labeler
- BF ASCHER AND CO INC
- Application
- M017
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2014-09-19
- Substance
- BENZYL ALCOHOL; PRAMOXINE HYDROCHLORIDE
- Active strength
- 10; 1 g/100g; g/100g
- Pharmacologic classes
- Pediculicide [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
- ITCH X
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| BENZYL ALCOHOL | 10 g/100g |
| PRAMOXINE HYDROCHLORIDE | 1 g/100g |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| LKG8494WBH | Internal UNII lookup |
| 88AYB867L5 | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 03c16d33-8f59-0184-e054-00144ff8d46c | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| c6f86816-7da6-43ea-8c25-ac9758311cc5 | Product name | 1 | 20220118 |
| 3c386306-c48a-413e-bb69-70cb268496f3 | Product name | 1 | 20210727 |
| 7792dadb-52b6-46b6-8fdf-80b1171065b5 | Product name | 1 | 20180810 |
| 252e11b6-1a9a-4283-a242-df2c129c496d | Product name | 3 | 20170717 |
| 58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8 | Product name | 1 | 20140508 |
| 9869efd7-d6dd-0665-5b67-53adbe6ef15e | Product name | 1 | 20140508 |
| a7051cba-790b-a699-81f8-dbbbdbd9b5ac | Product name | 1 | 20140508 |
| da108d9e-edc8-17a3-8c28-3251c6a8accc | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0225-0495-33 | ITCH X | 35.4 g in 1 TUBE | GEL | 35.4 | 6 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0225-0495-33 | GM - Gram | 0225-0495 | adf96dec-94ed-41d3-b853-e9b2a1ce7e47 | 1 | 2014-10-03 |
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 |
|---|---|---|---|---|---|---|
| Medicated Herbal Lip Balm | MENTHOL | Earth Mama Angel Baby LLC | 1cc2391e-6a7a-609c-e063-6394a90a6305 | 2024-10-01 | Warnings | M017 |
| CVS Health Lidocaine Plus Pain Relieving | LIDOCAINE HYDROCHLORIDE, BENZYL ALCOHOL | NATURAL ESSENTIALS, INC. | 1adb9b74-4a01-4461-b845-f3aedcb3f810 | 2024-10-01 | Warnings | M017 |
| Circata | CAPSAICIN | PureTek Corporation | b67161d7-cc5c-e971-e053-2995a90acbe7 | 2024-10-01 | Warnings | M017 |
| Menticam | CAMPHOR,MENTHOL, METHYL SALICYLATE | PureTek Corporation | ffea2e97-777f-434b-e053-6394a90a3a63 | 2024-10-01 | Warnings | M017 |
| Herb Street Sore Muscle Relief | METHYL SALICYLATE | Balassa Laboratories Inc. | e43943c2-d4cd-44c5-a0ff-403a8d42860f | 2024-10-01 | Warnings | M017 |
| hydrocortisone | HYDROCORTISONE | Kroger Company | 68dab606-0385-48b7-9a7b-a2cf83d20393 | 2024-09-29 | Warnings | M017 |
| kirkland signature hydrocortisone plus maximum strength | HYDROCORTISONE | Costco Wholesale Company | 481341c5-db1f-43fb-aed7-f40495a4eab8 | 2024-09-29 | Warnings | M017 |
| Care One hydrocortisone maximum strength | HYDROCORTISONE | American Sales Company | 32593229-d0ac-4d6c-831a-089fc6e76152 | 2024-09-29 | Warnings | M017 |
| good sense anti itch | HYDROCORTISONE | L. Perrigo Company | b7a896cc-1d78-45c0-a73e-aa1e117f7d3b | 2024-09-29 | Warnings | M017 |
| Topcare Hydrocortisone | HYDROCORTISONE | Topco Associates LLC | b7362f21-f1a3-4edc-b5b6-a16680e05df3 | 2024-09-29 | Warnings | M017 |
| hydrocortisone | HYDROCORTISONE | H E B | 412ca2d1-064b-4438-aee1-fcb5cf27c7db | 2024-09-29 | Warnings | M017 |
| Topcare Antibiotic | NEOMYCIN, POLYMYXIN B, PRAMOXINE HYDROCHLORIDE | Topco Associates LLC | 8c349cac-20e1-4600-9b0a-fcfe929551c5 | 2024-09-26 | Warnings | M017 |
| good sense anti itch | HYDROCORTISONE | A-S Medication Solutions | 072dd455-24a5-4a44-aaef-d3e137d005a6 | 2024-09-26 | Warnings | M017 |
| SYREN Intimate Relief | LIDOCAINE HYDROCHLORIDE | Icon Health Science | 57d5a080-3583-4510-e053-2a91aa0ad589 | 2024-09-25 | Warnings | M017 |
| AOSI HEALTHCARE | HYDROCORTISONE | Nantong Health & Beyond Hygienic Products Inc. | f4db90ad-dd62-44f1-9655-2614ed36581e | 2024-09-25 | Warnings | M017 |
| AOSI HEALTHCARE BURN | LIDOCAINE HYDROCHLORIDE, BENZALKONIUM CHLORIDE | Nantong Health & Beyond Hygienic Products Inc. | a28b920c-0bb8-4b5a-addd-26ea164e036e | 2024-09-25 | Warnings | M017 |
| anti itch | DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE | Kroger Company | 067e718a-ec0b-4895-8f9f-82d64ab4c7b4 | 2024-09-24 | Warnings | M017 |
| topcare anti itch | DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE | Topco Associates LLC | e0fb332a-2903-41ef-b35b-7cd3a74cff99 | 2024-09-24 | Warnings | M017 |
| equaline anti itch | HYDROCORTISONE | United Natural Foods, Inc. dba UNFI | 83cd9f60-a4c4-4dea-97a7-cd96aade9e88 | 2024-09-24 | Warnings | M017 |
| good sense itch relief | DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE | L. Perrigo Company | 162fe0a3-3995-4e6f-94ed-f839b2b0c80e | 2024-09-24 | Warnings | M017 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1293634 | Itch-X 10 % / 1 % Topical Gel | PSN | 03c16d33-8f59-0184-e054-00144ff8d46c | 6 |
| 1293632 | pramoxine HCl 1 % / benzyl alcohol 10 % Topical Gel | PSN | 03c16d33-8f59-0184-e054-00144ff8d46c | 6 |
| 1293634 | benzyl alcohol 0.1 ML/ML / pramoxine hydrochloride 0.01 MG/MG Topical Gel [Itch-X] | SBD | 03c16d33-8f59-0184-e054-00144ff8d46c | 6 |
| 1293632 | benzyl alcohol 0.1 ML/ML / pramoxine hydrochloride 0.01 MG/MG Topical Gel | SCD | 03c16d33-8f59-0184-e054-00144ff8d46c | 6 |
| 1293632 | benzyl alcohol 10 % / pramoxine hydrochloride 1 % Topical Gel | SY | 03c16d33-8f59-0184-e054-00144ff8d46c | 6 |
| 1293634 | Itch-X (benzyl alcohol 10 % / pramoxine hydrochloride 1 % ) Topical Gel | SY | 03c16d33-8f59-0184-e054-00144ff8d46c | 6 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0225-0495-33 | 00225049533 | 35.4 g in 1 TUBE (0225-0495-33) | 35.4 g | 2014-09-19 | 0000-00-00 | No | No | Current |