Home NDC 0025-0166 Synarel
Product NDC 0025-0166
11-digit product format 000250166
Labeler code 0025
Product ID 0025-0166_0ce07394-417b-4592-a051-8d63bdafbada
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name nafarelin acetate
Dosage form SPRAY, METERED
Route NASAL
Labeler Pfizer Laboratories Div Pfizer Inc
Application NDA019886
Marketing category NDA
Marketing start 1990-02-13
Substance NAFARELIN ACETATE
Active strength 2 mg/mL
Pharmacologic classes Gonadotropin Releasing Hormone Receptor Agonist [EPC], Gonadotropin Releasing Hormone Receptor Agonists [MoA]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N019886-001 SYNAREL NAFARELIN ACETATE EQ 0.2MG BASE/SPRAY SPRAY, METERED / NASAL RLD, RS 1990-02-13
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 · 42 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 N019886-001 SYNAREL EQ 0.2MG BASE/SPRAY SPRAY, METERED / NASAL RLD, RS 1990-02-13 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N019886-001 SYNAREL EQ 0.2MG BASE/SPRAY SPRAY, METERED / NASAL RLD, RS 1990-02-13 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019886-001 SYNAREL EQ 0.2MG BASE/SPRAY SPRAY, METERED / NASAL RLD, RS 1990-02-13 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N019886-001 SYNAREL EQ 0.2MG BASE/SPRAY SPRAY, METERED / NASAL RLD, RS 1990-02-13 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N019886-001 SYNAREL EQ 0.2MG BASE/SPRAY SPRAY, METERED / NASAL RLD, RS 1990-02-13 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N019886-001 SYNAREL EQ 0.2MG BASE/SPRAY SPRAY, METERED / NASAL RLD, RS 1990-02-13 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N019886-001 SYNAREL EQ 0.2MG BASE/SPRAY SPRAY, METERED / NASAL RLD, RS 1990-02-13 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N019886-001 SYNAREL EQ 0.2MG BASE/SPRAY SPRAY, METERED / NASAL RLD, RS 1990-02-13 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N019886-001 SYNAREL EQ 0.2MG BASE/SPRAY SPRAY, METERED / NASAL RLD, RS 1990-02-13 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N019886-001 SYNAREL EQ 0.2MG BASE/SPRAY SPRAY, METERED / NASAL RLD, RS 1990-02-13 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N019886-001 SYNAREL EQ 0.2MG BASE/SPRAY SPRAY, METERED / NASAL RLD, RS 1990-02-13 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N019886-001 SYNAREL EQ 0.2MG BASE/SPRAY SPRAY, METERED / NASAL RLD, RS 1990-02-13 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N019886-001 SYNAREL EQ 0.2MG BASE/SPRAY SPRAY, METERED / NASAL RLD, RS 1990-02-13 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N019886-001 SYNAREL EQ 0.2MG BASE/SPRAY SPRAY, METERED / NASAL RLD, RS 1990-02-13 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N019886-001 SYNAREL EQ 0.2MG BASE/SPRAY SPRAY, METERED / NASAL RLD, RS 1990-02-13 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N019886-001 SYNAREL EQ 0.2MG BASE/SPRAY SPRAY, METERED / NASAL RLD, RS 1990-02-13 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N019886-001 SYNAREL EQ 0.2MG BASE/SPRAY SPRAY, METERED / NASAL RLD, RS 1990-02-13 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N019886-001 SYNAREL EQ 0.2MG BASE/SPRAY SPRAY, METERED / NASAL RLD, RS 1990-02-13 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N019886-001 SYNAREL EQ 0.2MG BASE/SPRAY SPRAY, METERED / NASAL RLD, RS 1990-02-13 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N019886-001 SYNAREL EQ 0.2MG BASE/SPRAY SPRAY, METERED / NASAL RLD, RS 1990-02-13 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N019886-001 SYNAREL EQ 0.2MG BASE/SPRAY SPRAY, METERED / NASAL RLD, RS 1990-02-13 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N019886-001 SYNAREL EQ 0.2MG BASE/SPRAY SPRAY, METERED / NASAL RLD, RS 1990-02-13 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N019886-001 SYNAREL EQ 0.2MG BASE/SPRAY SPRAY, METERED / NASAL RLD, RS 1990-02-13 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N019886-001 SYNAREL EQ 0.2MG BASE/SPRAY SPRAY, METERED / NASAL RLD, RS 1990-02-13 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N019886-001 SYNAREL EQ 0.2MG BASE/SPRAY SPRAY, METERED / NASAL RLD, RS 1990-02-13 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N019886-001 SYNAREL EQ 0.2MG BASE/SPRAY SPRAY, METERED / NASAL RLD, RS 1990-02-13 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N019886-001 SYNAREL EQ 0.2MG BASE/SPRAY SPRAY, METERED / NASAL RLD, RS 1990-02-13 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N019886-001 SYNAREL EQ 0.2MG BASE/SPRAY SPRAY, METERED / NASAL RLD, RS 1990-02-13 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N019886-001 SYNAREL EQ 0.2MG BASE/SPRAY SPRAY, METERED / NASAL RLD, RS 1990-02-13 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N019886-001 SYNAREL EQ 0.2MG BASE/SPRAY SPRAY, METERED / NASAL RLD, RS 1990-02-13 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N019886-001 SYNAREL EQ 0.2MG BASE/SPRAY SPRAY, METERED / NASAL RLD, RS 1990-02-13 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N019886-001 SYNAREL EQ 0.2MG BASE/SPRAY SPRAY, METERED / NASAL RLD, RS 1990-02-13 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N019886-001 SYNAREL EQ 0.2MG BASE/SPRAY SPRAY, METERED / NASAL RLD, RS 1990-02-13 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N019886-001 SYNAREL EQ 0.2MG BASE/SPRAY SPRAY, METERED / NASAL RLD, RS 1990-02-13 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N019886-001 SYNAREL EQ 0.2MG BASE/SPRAY SPRAY, METERED / NASAL RLD, RS 1990-02-13 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N019886-001 SYNAREL EQ 0.2MG BASE/SPRAY SPRAY, METERED / NASAL RLD, RS 1990-02-13 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N019886-001 SYNAREL EQ 0.2MG BASE/SPRAY SPRAY, METERED / NASAL RLD, RS 1990-02-13 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N019886-001 SYNAREL EQ 0.2MG BASE/SPRAY SPRAY, METERED / NASAL RLD, RS 1990-02-13 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N019886-001 SYNAREL EQ 0.2MG BASE/SPRAY SPRAY, METERED / NASAL RLD, RS 1990-02-13 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N019886-001 SYNAREL EQ 0.2MG BASE/SPRAY SPRAY, METERED / NASAL RLD, RS 1990-02-13 e64feba35796…
Additional Listing Data#
Finished product Yes
Brand name base Synarel
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength NAFARELIN ACETATE 2 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 8ENZ0QJW4H Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1797878 Internal RxNorm lookup 1797880 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0025-0166-08 Synarel 1 in 1 CARTON SPRAY, METERED 1 23 0025-0166-08 Synarel 8 mL in 1 BOTTLE, SPRAY SPRAY, METERED 8 23
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded NAFARELIN ACETATE ACTIVE INGREDIENT 8ENZ0QJW4H SYNAREL (NAFARELIN ACETATE) SPRAY, METERED [G.D. SEARLE LLC DIVISION OF PFIZER INC] 12 NAFARELIN ACTIVE MOIETY 1X0094V6JV SYNAREL (NAFARELIN ACETATE) SPRAY, METERED [G.D. SEARLE LLC DIVISION OF PFIZER INC] 12 ACETIC ACID INACTIVE INGREDIENT Q40Q9N063P SYNAREL (NAFARELIN ACETATE) SPRAY, METERED [G.D. SEARLE LLC DIVISION OF PFIZER INC] 12 BENZALKONIUM CHLORIDE INACTIVE INGREDIENT F5UM2KM3W7 SYNAREL (NAFARELIN ACETATE) SPRAY, METERED [G.D. SEARLE LLC DIVISION OF PFIZER INC] 12 HYDROCHLORIC ACID INACTIVE INGREDIENT QTT17582CB SYNAREL (NAFARELIN ACETATE) SPRAY, METERED [G.D. SEARLE LLC DIVISION OF PFIZER INC] 12 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I SYNAREL (NAFARELIN ACETATE) SPRAY, METERED [G.D. SEARLE LLC DIVISION OF PFIZER INC] 12 SORBITOL INACTIVE INGREDIENT 506T60A25R SYNAREL (NAFARELIN ACETATE) SPRAY, METERED [G.D. SEARLE LLC DIVISION OF PFIZER INC] 12 WATER INACTIVE INGREDIENT 059QF0KO0R SYNAREL (NAFARELIN ACETATE) SPRAY, METERED [G.D. SEARLE LLC DIVISION OF PFIZER INC] 12
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0025-0166 SYNAREL (NAFARELIN ACETATE) SPRAY, METERED [PFIZER LABORATORIES DIV PFIZER INC] 21 Current NDC, Legacy NDC, 2 package rows 20230301_d0aa57cb-d2f4-46d7-af43-7c8b06aa81a6.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 Synarel NAFARELIN ACETATE Pfizer Laboratories Div Pfizer Inc d0aa57cb-d2f4-46d7-af43-7c8b06aa81a6 2026-03-05 Warnings, Adverse reactions Exact identifier application applno (NDA): 019886 application number: NDA019886 ndc (product): 0025-0166
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 0025-0166-08 00025016608 1 BOTTLE, SPRAY in 1 CARTON (0025-0166-08) / 8 mL in 1 BOTTLE, SPRAY 1990-02-13 0000-00-00 No No Current