GETTIK Hair Regrowth Treatment

Product NDC
71700-112
Requested package NDC
71700-112-05
11-digit product format
717000112
Labeler code
71700
Product ID
71700-112_f0d6f7d7-391a-9973-e053-2a95a90a10a0
Type
HUMAN OTC DRUG
Nonproprietary name
MINOXIDIL 5%
Dosage form
LIQUID
Route
TOPICAL
Labeler
GETTIK International LLC
Application
ANDA074588
Marketing category
ANDA
Marketing start
2017-10-01
Marketing end
0000-00-00
Substance
MINOXIDIL
Active strength
50 mg/mL
Pharmacologic classes
Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage71700-11271700-112-05IInactivated by FDA2026-08-03

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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage71700-11271700-112-05IInactivated by FDAexcluded / ndc_excluded.zip9bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage71700-11271700-112-05EExcluded after deficient or non-compliant submission was not correctedexcluded / ndc_excluded.zip110d247fa046…a55b01930146…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A074588-001MINOXIDIL (FOR MEN)MINOXIDIL2%SOLUTION / TOPICAL1996-04-05

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A074588-001MINOXIDIL (FOR MEN)2%SOLUTION / TOPICAL1996-04-05011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074588-001MINOXIDIL (FOR MEN)2%SOLUTION / TOPICAL1996-04-0531067a03dcf5…
2025-08-23 18:47 UTC2025-08A074588-001MINOXIDIL (FOR MEN)2%SOLUTION / TOPICAL1996-04-056a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074588-001MINOXIDIL (FOR MEN)2%SOLUTION / TOPICAL1996-04-05fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074588-001MINOXIDIL (FOR MEN)2%SOLUTION / TOPICAL1996-04-05b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074588-001MINOXIDIL (FOR MEN)2%SOLUTION / TOPICAL1996-04-0503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074588-001MINOXIDIL (FOR MEN)2%SOLUTION / TOPICAL1996-04-052680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074588-001MINOXIDIL (FOR MEN)2%SOLUTION / TOPICAL1996-04-055bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074588-001MINOXIDIL (FOR MEN)2%SOLUTION / TOPICAL1996-04-05d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A074588-001MINOXIDIL (FOR MEN)2%SOLUTION / TOPICAL1996-04-05d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074588-001MINOXIDIL (FOR MEN)2%SOLUTION / TOPICAL1996-04-0579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074588-001MINOXIDIL (FOR MEN)2%SOLUTION / TOPICAL1996-04-05301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074588-001MINOXIDIL (FOR MEN)2%SOLUTION / TOPICAL1996-04-051e350fbaab3a…
2024-05-31 18:47 UTC2024-05A074588-001MINOXIDIL (FOR MEN)2%SOLUTION / TOPICAL1996-04-058072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A074588-001MINOXIDIL (FOR MEN)2%SOLUTION / TOPICAL1996-04-055c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A074588-001MINOXIDIL (FOR MEN)2%SOLUTION / TOPICAL1996-04-055d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A074588-001MINOXIDIL (FOR MEN)2%SOLUTION / TOPICAL1996-04-054b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A074588-001MINOXIDIL (FOR MEN)2%SOLUTION / TOPICAL1996-04-0574a2ff9319b5…
2022-03-09 01:35 UTC2022-03A074588-001MINOXIDIL (FOR MEN)2%SOLUTION / TOPICAL1996-04-05bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A074588-001MINOXIDIL (FOR MEN)2%SOLUTION / TOPICAL1996-04-05782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A074588-001MINOXIDIL (FOR MEN)2%SOLUTION / TOPICAL1996-04-0587673890dc5c…
2021-03-12 10:30 UTC2021-03A074588-001MINOXIDIL (FOR MEN)2%SOLUTION / TOPICAL1996-04-055aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A074588-001MINOXIDIL (FOR MEN)2%SOLUTION / TOPICAL1996-04-058869cabd3fbd…
2020-11-12 02:37 UTC2020-11A074588-001MINOXIDIL (FOR MEN)2%SOLUTION / TOPICAL1996-04-05c0c555d07b60…
2019-12-14 00:12 UTC2019-12A074588-001MINOXIDIL (FOR MEN)2%SOLUTION / TOPICAL1996-04-053f01610625f2…
2019-09-15 20:21 UTC2019-09A074588-001MINOXIDIL (FOR MEN)2%SOLUTION / TOPICAL1996-04-05b00525d2431f…
2019-07-19 19:46 UTC2019-07A074588-001MINOXIDIL (FOR MEN)2%SOLUTION / TOPICAL1996-04-05ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A074588-001MINOXIDIL (FOR MEN)2%SOLUTION / TOPICAL1996-04-056a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A074588-001MINOXIDIL (FOR MEN)2%SOLUTION / TOPICAL1996-04-051c564ffb4f44…
2023-12-20 04:57 UTC2023-12A074588-001MINOXIDIL (FOR MEN)2%SOLUTION / TOPICAL1996-04-05ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A074588-001MINOXIDIL (FOR MEN)2%SOLUTION / TOPICAL1996-04-05a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A074588-001MINOXIDIL (FOR MEN)2%SOLUTION / TOPICAL1996-04-059b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A074588-001MINOXIDIL (FOR MEN)2%SOLUTION / TOPICAL1996-04-05a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A074588-001MINOXIDIL (FOR MEN)2%SOLUTION / TOPICAL1996-04-053f0d92c62455…
2023-05-13 08:27 UTC2023-05A074588-001MINOXIDIL (FOR MEN)2%SOLUTION / TOPICAL1996-04-05053a50430f4f…
2023-01-26 05:58 UTC2023-01A074588-001MINOXIDIL (FOR MEN)2%SOLUTION / TOPICAL1996-04-053bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A074588-001MINOXIDIL (FOR MEN)2%SOLUTION / TOPICAL1996-04-053a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A074588-001MINOXIDIL (FOR MEN)2%SOLUTION / TOPICAL1996-04-05f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A074588-001MINOXIDIL (FOR MEN)2%SOLUTION / TOPICAL1996-04-05e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A074588-001MINOXIDIL (FOR MEN)2%SOLUTION / TOPICAL1996-04-05cb3db0bc1861…

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71700-112-052020-08-13C16284748780-19d75b9d0-c715-f424-e053-dadaa90a57ce57dbf5bb-d2b9-4a3a-e053-2a91aa0ae971
71700-112-052020-01-31C16284748780-19d75b9d0-c715-f424-e053-dadaa90a57ce57dbf5bb-d2b9-4a3a-e053-2a91aa0ae971

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71700-112-03GETTIK Hair Regrowth Treatment60 mL in 1 BOTTLE, PLASTICLIQUID6014
71700-112-03GETTIK Hair Regrowth Treatment1 in 1 BOXLIQUID114
71700-112-05GETTIK Hair Regrowth Treatment3 in 1 BOXLIQUID314
71700-112-05GETTIK Hair Regrowth Treatment60 mL in 1 BOTTLE, PLASTICLIQUID6014

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71700-112GETTIK HAIR REGROWTH TREATMENT (MINOXIDIL 5%) LIQUID [GETTIK INTERNATIONAL LLC]14Legacy NDC, 4 package rows20241212_57dbf5bb-d2b9-4a3a-e053-2a91aa0ae971.zip

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.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MinoxidilMINOXIDILWalgreensb55198cb-40d8-432b-bdd5-2ecefa35d3202025-05-21WarningsExact identifier
application applno (ANDA): 074588
application number: ANDA074588

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311724minoxidil 5 % Topical SolutionPSN57dbf5bb-d2b9-4a3a-e053-2a91aa0ae97114
311724minoxidil 50 MG/ML Topical SolutionSCD57dbf5bb-d2b9-4a3a-e053-2a91aa0ae97114
311724minoxidil 3 GM per 60 ML Topical SolutionSY57dbf5bb-d2b9-4a3a-e053-2a91aa0ae97114
311724minoxidil 5 % Topical SolutionSY57dbf5bb-d2b9-4a3a-e053-2a91aa0ae97114
311724minoxidil 5 GM per 100 ML Topical SolutionSY57dbf5bb-d2b9-4a3a-e053-2a91aa0ae97114

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71700-112-05717000112053 BOTTLE, PLASTIC in 1 BOX (71700-112-05) > 60 mL in 1 BOTTLE, PLASTIC2017-10-010000-00-00NoNoCurrent