Zzip Cold Sore Treatment

Product NDC
70019-100
11-digit product format
700190100
Labeler code
70019
Product ID
70019-100_9adde184-b4c5-4dfd-b2e0-a30ee8caff08
Type
HUMAN OTC DRUG
Nonproprietary name
ALLANTOIN, DIMETHICONE, MENTHOL
Dosage form
SOLUTION
Route
TOPICAL
Labeler
Zzip AG
Application
part348
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2015-07-30
Marketing end
0000-00-00
Substance
ALLANTOIN; DIMETHICONE; MENTHOL
Active strength
5 mg/mL; mg/mL; mg/mL
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct70019-100IInactivated by FDA2026-10-05
excluded packagepackage70019-10070019-100-00IInactivated by FDA2026-10-05

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.

Historic NDC status page 1 of 1 · 44 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductIInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage70019-100-00IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductIInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage70019-100-00IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductIInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage70019-100-00IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductIInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage70019-100-00IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductIInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage70019-100-00IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductIInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage70019-100-00IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductIInactivated by FDA302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage70019-100-00IInactivated by FDA302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductIInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage70019-100-00IInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductIInactivated by FDA0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage70019-100-00IInactivated by FDA0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductIInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage70019-100-00IInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductIInactivated by FDA367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage70019-100-00IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductIInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage70019-100-00IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproductIInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage70019-100-00IInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproductIInactivated by FDA834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage70019-100-00IInactivated by FDA834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproductIInactivated by FDA1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage70019-100-00IInactivated by FDA1332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductIInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage70019-100-00IInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproductIInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage70019-100-00IInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductIInactivated by FDAbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage70019-100-00IInactivated by FDAbd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproductIInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage70019-100-00IInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproductIInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage70019-100-00IInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproductIInactivated by FDA9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage70019-100-00IInactivated by FDA9bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproductEExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage70019-100-00EExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70019-100-002020-01-31C16284748780-19d75b9cf-eeac-f424-e053-dadaa90a57ceZzip Cold Sore Treatment

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70019-100-00Zzip Cold Sore Treatment3 mL in 1 TUBESOLUTION31

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ALLANTOINACTIVE INGREDIENT344S277G0ZZZIP COLD SORE TREATMENT (ALLANTOIN, DIMETHICONE, MENTHOL) SOLUTION [ZZIP AG]1
DIMETHICONEACTIVE INGREDIENT92RU3N3Y1OZZIP COLD SORE TREATMENT (ALLANTOIN, DIMETHICONE, MENTHOL) SOLUTION [ZZIP AG]1
MENTHOLACTIVE INGREDIENTL7T10EIP3AZZIP COLD SORE TREATMENT (ALLANTOIN, DIMETHICONE, MENTHOL) SOLUTION [ZZIP AG]1
ALLANTOINACTIVE MOIETY344S277G0ZZZIP COLD SORE TREATMENT (ALLANTOIN, DIMETHICONE, MENTHOL) SOLUTION [ZZIP AG]1
DIMETHICONEACTIVE MOIETY92RU3N3Y1OZZIP COLD SORE TREATMENT (ALLANTOIN, DIMETHICONE, MENTHOL) SOLUTION [ZZIP AG]1
MENTHOLACTIVE MOIETYL7T10EIP3AZZIP COLD SORE TREATMENT (ALLANTOIN, DIMETHICONE, MENTHOL) SOLUTION [ZZIP AG]1
ALOEINACTIVE INGREDIENTV5VD430YW9ZZIP COLD SORE TREATMENT (ALLANTOIN, DIMETHICONE, MENTHOL) SOLUTION [ZZIP AG]1
BASIC COPPER SULFATEINACTIVE INGREDIENTCUP529P5NSZZIP COLD SORE TREATMENT (ALLANTOIN, DIMETHICONE, MENTHOL) SOLUTION [ZZIP AG]1
CALENDULA OFFICINALIS FLOWERINACTIVE INGREDIENTP0M7O4Y7YDZZIP COLD SORE TREATMENT (ALLANTOIN, DIMETHICONE, MENTHOL) SOLUTION [ZZIP AG]1
ETHYLHEXYLGLYCERININACTIVE INGREDIENT147D247K3PZZIP COLD SORE TREATMENT (ALLANTOIN, DIMETHICONE, MENTHOL) SOLUTION [ZZIP AG]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXZZIP COLD SORE TREATMENT (ALLANTOIN, DIMETHICONE, MENTHOL) SOLUTION [ZZIP AG]1
LAURETH-9INACTIVE INGREDIENT0AWH8BFG9AZZIP COLD SORE TREATMENT (ALLANTOIN, DIMETHICONE, MENTHOL) SOLUTION [ZZIP AG]1
MALTODEXTRININACTIVE INGREDIENT7CVR7L4A2DZZIP COLD SORE TREATMENT (ALLANTOIN, DIMETHICONE, MENTHOL) SOLUTION [ZZIP AG]1
OPUNTIA FICUS-INDICA STEMINACTIVE INGREDIENTMUD8892KHLZZIP COLD SORE TREATMENT (ALLANTOIN, DIMETHICONE, MENTHOL) SOLUTION [ZZIP AG]1
PEG-40 CASTOR OILINACTIVE INGREDIENT4ERD2076EFZZIP COLD SORE TREATMENT (ALLANTOIN, DIMETHICONE, MENTHOL) SOLUTION [ZZIP AG]1
PENTYLENE GLYCOLINACTIVE INGREDIENT50C1307PZGZZIP COLD SORE TREATMENT (ALLANTOIN, DIMETHICONE, MENTHOL) SOLUTION [ZZIP AG]1
TRIDECETH-9INACTIVE INGREDIENTX9HD79I514ZZIP COLD SORE TREATMENT (ALLANTOIN, DIMETHICONE, MENTHOL) SOLUTION [ZZIP AG]1
WATERINACTIVE INGREDIENT059QF0KO0RZZIP COLD SORE TREATMENT (ALLANTOIN, DIMETHICONE, MENTHOL) SOLUTION [ZZIP AG]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70019-100ZZIP COLD SORE TREATMENT (ALLANTOIN, DIMETHICONE, MENTHOL) SOLUTION [ZZIP AG]1Legacy NDC, 1 package rows20150731_cf62370a-9a10-46b1-b320-23eaf196040c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1659645allantoin 0.5 % / dimethicone 1 % / menthol 0.1 % Topical SolutionPSNcf62370a-9a10-46b1-b320-23eaf196040c1
1659650Zzip Cold Sore (allantoin 0.5 % / dimethicone 1 % / menthol 0.1 % ) Topical SolutionPSNcf62370a-9a10-46b1-b320-23eaf196040c1
1659650allantoin 5 MG/ML / dimethicone 10 MG/ML / menthol 1 MG/ML Topical Solution [Zzip]SBDcf62370a-9a10-46b1-b320-23eaf196040c1
1659645allantoin 5 MG/ML / dimethicone 10 MG/ML / menthol 1 MG/ML Topical SolutionSCDcf62370a-9a10-46b1-b320-23eaf196040c1
1659645allantoin 0.5 % / dimethicone 1 % / menthol 0.1 % Topical SolutionSYcf62370a-9a10-46b1-b320-23eaf196040c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
70019-100-00700190100003 mL in 1 TUBE3 mlHistorical