Home NDC 68391-133 Berkley and Jensen Allergy Relief
Product NDC 68391-133
11-digit product format 683910133
Labeler code 68391
Product ID 68391-133_1c9af35f-9524-4371-82ef-c5d10c72ba5d
Type HUMAN OTC DRUG
Nonproprietary name Fluticasone propionate
Dosage form SPRAY, METERED
Route NASAL
Labeler BJWC
Application ANDA207957
Marketing category ANDA
Marketing start 2016-06-27
Marketing end 0000-00-00
Substance FLUTICASONE PROPIONATE
Active strength 50 ug/1
Pharmacologic classes Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag No
Listing certified through 2023-12-31
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 · 24 matching rows.
View current auxiliary records. · View the auxiliary file history.
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 A207957-001 FLUTICASONE PROPIONATE FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL RS 2016-05-26
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 A207957-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL RS 2016-05-26 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A207957-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL RS 2016-05-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207957-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL RS 2016-05-26 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A207957-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL RS 2016-05-26 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207957-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL RS 2016-05-26 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207957-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL RS 2016-05-26 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207957-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL RS 2016-05-26 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207957-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL RS 2016-05-26 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207957-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL RS 2016-05-26 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A207957-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL RS 2016-05-26 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A207957-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL RS 2016-05-26 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A207957-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL RS 2016-05-26 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A207957-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL RS 2016-05-26 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A207957-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL RS 2016-05-26 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A207957-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL RS 2016-05-26 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A207957-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL RS 2016-05-26 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A207957-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL RS 2016-05-26 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A207957-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL RS 2016-05-26 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A207957-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL 2016-05-26 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A207957-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL RS 2016-05-26 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A207957-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL RS 2016-05-26 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A207957-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL 2016-05-26 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A207957-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL 2016-05-26 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A207957-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL 2016-05-26 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A207957-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL 2016-05-26 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A207957-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL 2016-05-26 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A207957-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL 2016-05-26 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A207957-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL 2016-05-26 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A207957-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL RS 2016-05-26 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A207957-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL RS 2016-05-26 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A207957-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL RS 2016-05-26 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A207957-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL RS 2016-05-26 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A207957-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL RS 2016-05-26 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A207957-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL RS 2016-05-26 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A207957-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL RS 2016-05-26 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A207957-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL RS 2016-05-26 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A207957-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL RS 2016-05-26 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A207957-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL RS 2016-05-26 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A207957-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL RS 2016-05-26 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A207957-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL RS 2016-05-26 e64feba35796…
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 68391-133-04 Berkley and Jensen Allergy Relief 120 in 1 BOTTLE SPRAY, METERED 120 6 68391-133-04 Berkley and Jensen Allergy Relief 3 in 1 CARTON SPRAY, METERED 3 6 68391-133-07 Berkley and Jensen Allergy Relief 120 in 1 BOTTLE SPRAY, METERED 120 6 68391-133-07 Berkley and Jensen Allergy Relief 4 in 1 CARTON SPRAY, METERED 4 6 68391-133-12 Berkley and Jensen Allergy Relief 4 in 1 CARTON SPRAY, METERED 4 6 68391-133-12 Berkley and Jensen Allergy Relief 144 in 1 BOTTLE SPRAY, METERED 144 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68391-133 BERKLEY AND JENSEN ALLERGY RELIEF (FLUTICASONE PROPIONATE) SPRAY, METERED [BJWC] 6 Legacy NDC, 6 package rows 20221108_0e0f36b2-e5ef-40b1-9efe-5fda36491e01.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 3 · 43 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 68391-133-04 68391013304 3 BOTTLE in 1 CARTON (68391-133-04) > 120 SPRAY, METERED in 1 BOTTLE 3 bottle 2016-06-27 0000-00-00 No No Current 68391-133-07 68391013307 4 BOTTLE in 1 CARTON (68391-133-07) > 120 SPRAY, METERED in 1 BOTTLE 4 bottle 2019-07-16 2023-03-01 No No Current 68391-133-12 68391013312 4 BOTTLE in 1 CARTON (68391-133-12) > 144 SPRAY, METERED in 1 BOTTLE 4 bottle 2021-03-18 0000-00-00 No No Current