Hongocura
- Product NDC
- 53145-219
- 11-digit product format
- 531450219
- Labeler code
- 53145
- Product ID
- 53145-219_3a8a5464-a254-ca2c-e063-6294a90aa0fe
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Undecylenic Acid
- Dosage form
- SPRAY
- Route
- TOPICAL
- Labeler
- MENPER DISTRIBUTORS, INC.
- Application
- M005
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2020-04-06
- Substance
- UNDECYLENIC ACID
- Active strength
- 20 mg/100mL
- 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 | Code | Status | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|---|---|
| 2020-12-18 03:04 UTC · source 2020-12-17 | excluded product | product | I | Inactivated by FDA | e2bbac7714bc… | 27bdfed8d636… | |
| 2020-12-18 03:04 UTC · source 2020-12-17 | excluded package | package | 53145-219-03 | I | Inactivated by FDA | e2bbac7714bc… | 27bdfed8d636… |
| 2020-06-10 20:45 UTC · source 2020-06-10 | excluded product | product | I | Inactivated by FDA | 9bebd1f3094a… | 5416666fcb17… | |
| 2020-06-10 20:45 UTC · source 2020-06-10 | excluded package | package | 53145-219-03 | I | Inactivated by FDA | 9bebd1f3094a… | 5416666fcb17… |
| 2019-12-08 06:16 UTC · source 2019-12-05 | excluded product | product | E | Excluded after deficient or non-compliant submission was not corrected | 110d247fa046… | a55b01930146… | |
| 2019-12-08 06:16 UTC · source 2019-12-05 | excluded package | package | 53145-219-03 | E | Excluded after deficient or non-compliant submission was not corrected | 110d247fa046… | a55b01930146… |
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
- Hongocura
- Brand name suffix
- M
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| UNDECYLENIC ACID | 20 mg/100mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| K3D86KJ24N | Internal UNII lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| b4adb7b0-59b4-4b3c-9b0e-1869bb543174 | Available on FDA.report |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 53145-219-03 | 2023-07-28 | C162847 | 48780-1 | 9d75b9d0-afdb-f424-e053-dadaa90a57ce | Hongocura M |
| 53145-219-03 | 2021-04-17 | C162847 | 48780-1 | 9d75b9d0-afdb-f424-e053-dadaa90a57ce | Hongocura M |
| 53145-219-03 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-afdb-f424-e053-dadaa90a57ce | Hongocura M |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 53145-219-03 | HongocuraM | 60 mL in 1 BOTTLE, SPRAY | SPRAY | 60 | 8 | |
| 53145-219-03 | HongocuraM | 1 in 1 CARTON | SPRAY | 1 | 8 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| UNDECYLENIC ACID | ACTIVE INGREDIENT | K3D86KJ24N | HONGOCURA M (UNDECYLENIC ACID) LIQUID [MENPER DISTRIBUTORS, INC.] | 2 | |
| UNDECYLENIC ACID | ACTIVE MOIETY | K3D86KJ24N | HONGOCURA M (UNDECYLENIC ACID) LIQUID [MENPER DISTRIBUTORS, INC.] | 2 | |
| ISOPROPYL ALCOHOL | INACTIVE INGREDIENT | ND2M416302 | HONGOCURA M (UNDECYLENIC ACID) LIQUID [MENPER DISTRIBUTORS, INC.] | 2 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | HONGOCURA M (UNDECYLENIC ACID) LIQUID [MENPER DISTRIBUTORS, INC.] | 2 |
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 |
|---|---|---|---|---|---|---|
| Medi-First Clotrimazole 1% ANTIFUNGAL Cream | CLOTRIMAZOLE | Unifirst First Aid Corporation | 522eeb91-8378-32f4-e063-6394a90aff43 | 2026-05-20 | Warnings | M005 |
| Kopa Haiku Antifungal Cream | MICONAZOLE NITRATE 2% | Trovina Co. Ltd | 47cf1251-5965-045a-e063-6394a90ab04f | 2026-05-19 | Warnings | M005 |
| APUREE PRO Nailtific Maximum Strength Antifungal Patches | APUREE PRO NAILTIFIC MAXIMUM STRENGTH ANTIFUNGAL PATCHES | Guangzhou Meixi Biotechnology Co., Ltd. | 5218bd5d-53b4-107f-e063-6394a90ae769 | 2026-05-18 | M005 | |
| APUREE Pro Nailtific Maximum Strength Dual-Action Antifungal Pen | APUREE PRO NAILTIFIC MAXIMUM STRENGTH DUAL-ACTION ANTIFUNGAL PEN | Guangzhou Meixi Biotechnology Co., Ltd. | 521a0e40-a218-fabb-e063-6294a90ae9a2 | 2026-05-18 | Warnings | M005 |
| Beukow Antifungal Pen | UNDECYLENIC ACID 25% ANTIFUNGAL PEN | Jiangxi Yudexi Pharmaceutical Co., LTD | 511d1edf-dfda-477c-e063-6294a90aa423 | 2026-05-17 | Warnings | M005 |
| Nail Repair Pen | NAIL REPAIR PEN | Shenzhen Earth Surface Trading Co., Ltd. | 520f6514-6660-d6a8-e063-6394a90adf82 | 2026-05-17 | Warnings | M005 |
| Fungicure Intensive | CLOTRIMAZOLE | Kobayashi Healthcare International, Inc. | 1f1b413f-278e-434f-8590-4cf731663f5c | 2026-05-15 | Warnings | M005 |
| Dr Scholls Fungal Nail Clear and Cure Tolnaftate Antifungal | TOLNAFTATE | Scholl's Wellness Company LLC | 8abd6d8e-c69e-4374-ace8-d42b2d3e171e | 2026-05-14 | Warnings | M005 |
| Dr.Scholl s Odor X Athlete s Foot | TOLNAFTATE | Scholl's Wellness Company LLC | 0e864882-5e00-491e-a008-0762c131637a | 2026-05-14 | Warnings | M005 |
| Athletes Foot | TOLNAFTATE | Rugby Laboratories | 50c46cf5-3e64-9e0f-e063-6294a90a2317 | 2026-05-14 | Warnings | M005 |
| TOSSOYA Rainforest SecretGuard Antibacterial Quick-Cleanse Wipes | TOSSOYA RAINFOREST SECRETGUARD ANTIBACTERIAL QUICK-CLEANSE WIPES | Shenzhen Shierjie Biological Engineering Co., LTD | 3d53463d-8d8e-9030-e063-6294a90ab454 | 2026-05-13 | Warnings | M005 |
| Anti-Fungal Powder | MICONAZOLE NITRATE | CVS Pharmacy | 1651bdd7-ab15-7a2d-e063-6294a90a8b91 | 2026-05-11 | Warnings | M005 |
| Lightning X Hand Cleanser | ETHYL ALCOHOL | Nantong Health & Beyond Hygienic Products Inc. | 51861f1e-8961-e876-e063-6394a90a2fd0 | 2026-05-11 | Warnings | M005 |
| APUREE Nailtific Maximum Strength Antifungal Patches PRO | APUREE NAILTIFIC MAXIMUM STRENGTH ANTIFUNGAL PATCHES PRO | Guangzhou Meixi Biotechnology Co., Ltd | 5189ebc5-8ee5-1b2c-e063-6294a90af5c8 | 2026-05-11 | Warnings | M005 |
| APUREE Nailtific Maximum Strength Dual-Action Antifungal Pen Pro | APUREE NAILTIFIC MAXIMUM STRENGTH DUAL-ACTION ANTIFUNGAL PEN PRO | Guangzhou Meixi Biotechnology Co., Ltd. | 518abf2b-6ac8-ab9b-e063-6294a90ae693 | 2026-05-11 | Warnings | M005 |
| CLOTRIMAZOLE | CLOTRIMAZOLE | Rugby Laboratories, Inc. | 2c60e631-5930-4420-886d-eb1990c720b6 | 2026-05-11 | Warnings | M005 |
| Tolfyra | TOLNAFTATE | Oncora Pharma, LLC | b28ee9f2-fc45-4336-b374-be7aa51d44e9 | 2026-05-11 | Warnings | M005 |
| clotrimazole | CLOTRIMAZOLE | A-S Medication Solutions | c0f58a0d-a304-41f9-bbdf-c2e488230cf0 | 2026-05-11 | Warnings | M005 |
| Inlifay ANTIFUNGAL | TOLNAFTATE | Guangdong Aimu Biological Technology Co., Ltd | 5148b838-d26e-cf66-e063-6394a90ae469 | 2026-05-09 | Warnings | M005 |
| HuiPoLii NAIL PFLASTER | TOLNAFTATE 1% NAIL PFLASTER | Jiangxi Yudexi Pharmaceutical Co., LTD | 514b1c2d-cecb-30a2-e063-6394a90af266 | 2026-05-08 | Warnings | M005 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 53145-219-03 | 53145021903 | 1 BOTTLE, SPRAY in 1 CARTON (53145-219-03) / 60 mL in 1 BOTTLE, SPRAY | 2020-04-06 | 0000-00-00 | No | No | Current |