Home NDC 55056-0406 Prochieve
Product NDC 55056-0406
11-digit product format 550560406
Labeler code 55056
Product ID 55056-0406_6ea8a930-2eae-435e-b13c-f2c9e9a4bf00
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name progesterone
Dosage form GEL
Route VAGINAL
Labeler Columbia Laboratories
Application NDA020701
Marketing category NDA
Marketing start 1997-05-13
Marketing end 0000-00-00
Substance PROGESTERONE
Active strength 45 mg/1.125g
Pharmacologic classes Progesterone [CS],Progesterone [EPC]
NDC exclude flag E
Listing certified through 2017-12-31
Current FDA listing Historical FDA.report record 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 date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 55056-0406-1 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 55056-0406-1 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 55056-0406-1 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 55056-0406-1 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 55056-0406-1 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 55056-0406-1 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 55056-0406-1 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 55056-0406-1 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 55056-0406-1 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 55056-0406-1 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 55056-0406-1 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 55056-0406-1 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 55056-0406-1 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 55056-0406-1 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 55056-0406-1 1332a3947898…d4bfe170f9cd…2022-08-30 03:57 UTC · source 2022-08-29 excluded product product fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 55056-0406-1 fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 excluded product product 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 55056-0406-1 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded product product bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 55056-0406-1 bd6a592717d7…303034d00443…2021-12-27 23:28 UTC · source 2021-12-27 excluded product product 8dfbde2a14a4…c9ff85d89658…2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 55056-0406-1 8dfbde2a14a4…c9ff85d89658…2020-12-18 03:04 UTC · source 2020-12-17 excluded product product e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 55056-0406-1 e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 55056-0406-1 9bebd1f3094a…5416666fcb17…2019-12-08 06:16 UTC · source 2019-12-05 excluded product product 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 55056-0406-1 110d247fa046…a55b01930146…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N020701-001 CRINONE PROGESTERONE 4% GEL / VAGINAL RLD 1997-07-31 N020701-002 CRINONE PROGESTERONE 8% GEL / VAGINAL RLD, RS 1997-07-31
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 3 · 84 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 N020701-001 CRINONE 4% GEL / VAGINAL RLD 1997-07-31 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N020701-002 CRINONE 8% GEL / VAGINAL RLD, RS 1997-07-31 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N020701-001 CRINONE 4% GEL / VAGINAL RLD, RS 1997-07-31 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020701-002 CRINONE 8% GEL / VAGINAL RLD, RS 1997-07-31 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020701-001 CRINONE 4% GEL / VAGINAL RLD, RS 1997-07-31 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020701-002 CRINONE 8% GEL / VAGINAL RLD, RS 1997-07-31 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020701-001 CRINONE 4% GEL / VAGINAL RLD, RS 1997-07-31 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020701-002 CRINONE 8% GEL / VAGINAL RLD, RS 1997-07-31 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020701-001 CRINONE 4% GEL / VAGINAL RLD, RS 1997-07-31 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020701-002 CRINONE 8% GEL / VAGINAL RLD, RS 1997-07-31 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020701-001 CRINONE 4% GEL / VAGINAL RLD, RS 1997-07-31 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020701-002 CRINONE 8% GEL / VAGINAL RLD, RS 1997-07-31 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020701-001 CRINONE 4% GEL / VAGINAL RLD, RS 1997-07-31 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020701-002 CRINONE 8% GEL / VAGINAL RLD, RS 1997-07-31 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020701-001 CRINONE 4% GEL / VAGINAL RLD, RS 1997-07-31 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020701-002 CRINONE 8% GEL / VAGINAL RLD, RS 1997-07-31 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020701-001 CRINONE 4% GEL / VAGINAL RLD, RS 1997-07-31 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020701-002 CRINONE 8% GEL / VAGINAL RLD, RS 1997-07-31 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020701-001 CRINONE 4% GEL / VAGINAL RLD, RS 1997-07-31 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020701-002 CRINONE 8% GEL / VAGINAL RLD, RS 1997-07-31 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N020701-001 CRINONE 4% GEL / VAGINAL RLD, RS 1997-07-31 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N020701-002 CRINONE 8% GEL / VAGINAL RLD, RS 1997-07-31 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020701-001 CRINONE 4% GEL / VAGINAL RLD, RS 1997-07-31 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020701-002 CRINONE 8% GEL / VAGINAL RLD, RS 1997-07-31 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020701-001 CRINONE 4% GEL / VAGINAL RLD, RS 1997-07-31 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020701-002 CRINONE 8% GEL / VAGINAL RLD, RS 1997-07-31 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020701-001 CRINONE 4% GEL / VAGINAL RLD, RS 1997-07-31 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020701-002 CRINONE 8% GEL / VAGINAL RLD, RS 1997-07-31 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N020701-001 CRINONE 4% GEL / VAGINAL RLD, RS 1997-07-31 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N020701-002 CRINONE 8% GEL / VAGINAL RLD, RS 1997-07-31 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020701-001 CRINONE 4% GEL / VAGINAL RLD, RS 1997-07-31 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020701-002 CRINONE 8% GEL / VAGINAL RLD, RS 1997-07-31 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N020701-001 CRINONE 4% GEL / VAGINAL RLD, RS 1997-07-31 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N020701-002 CRINONE 8% GEL / VAGINAL RLD, RS 1997-07-31 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N020701-001 CRINONE 4% GEL / VAGINAL RLD, RS 1997-07-31 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N020701-002 CRINONE 8% GEL / VAGINAL RLD, RS 1997-07-31 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N020701-001 CRINONE 4% GEL / VAGINAL RLD, RS 1997-07-31 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N020701-002 CRINONE 8% GEL / VAGINAL RLD, RS 1997-07-31 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N020701-001 CRINONE 4% GEL / VAGINAL RLD, RS 1997-07-31 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N020701-002 CRINONE 8% GEL / VAGINAL RLD, RS 1997-07-31 bb7c543d1eb4…
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 55056-0406-1 Prochieve 1.125 g in 1 APPLICATOR GEL 1.125 1 55056-0406-1 Prochieve 6 in 1 CARTON GEL 6 1
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55056-0406 PROCHIEVE (PROGESTERONE) GEL [COLUMBIA LABORATORIES] 1 Legacy NDC, 2 package rows 20091214_9f8dc923-65d7-42ff-b718-97e7a7e87822.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 Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Crinone PROGESTERONE Allergan, Inc. 75e97aa1-daa4-45f9-b2e2-1a371302914e 2024-05-21 Warnings, Adverse reactions Exact identifier application applno (NDA): 020701 application number: NDA020701
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Status 55056-0406-1 55056040601 1.125 g in 1 APPLICATOR 1.125 g Historical