BECONASE

Product NDC
0173-0388
11-digit product format
001730388
Labeler code
0173
Product ID
0173-0388_6b481c61-644f-4c6b-9b7e-93cda74e25a2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
beclomethasone dipropionate monohydrate
Dosage form
SPRAY, SUSPENSION
Route
NASAL
Labeler
GlaxoSmithKline LLC
Application
NDA019389
Marketing category
NDA
Marketing start
1989-10-01
Marketing end
0000-00-00
Substance
BECLOMETHASONE DIPROPIONATE MONOHYDRATE
Active strength
42 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

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 productproduct0173-0388DDiscontinued by firm2026-10-05
excluded packagepackage0173-03880173-0388-79DDiscontinued by firm2026-10-05

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 · 4 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0173-0388-79d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0173-0388-79f5e01cc5f278…a2eaf40c39c3…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
N019389-001BECONASE AQBECLOMETHASONE DIPROPIONATE MONOHYDRATEEQ 0.042MG DIPROP/SPRAYSPRAY, METERED / NASALRLD1987-07-27

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 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N019389-001BECONASE AQEQ 0.042MG DIPROP/SPRAYSPRAY, METERED / NASALRLD1987-07-2784e616aacf4f…
2026-08-18 06:07:402026-07N019389-001BECONASE AQEQ 0.042MG DIPROP/SPRAYSPRAY, METERED / NASALRLD1987-07-27caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N019389-001BECONASE AQEQ 0.042MG DIPROP/SPRAYSPRAY, METERED / NASALRLD1987-07-27011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019389-001BECONASE AQEQ 0.042MG DIPROP/SPRAYSPRAY, METERED / NASALRLD1987-07-2731067a03dcf5…
2025-08-23 18:47 UTC2025-08N019389-001BECONASE AQEQ 0.042MG DIPROP/SPRAYSPRAY, METERED / NASALRLD1987-07-276a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019389-001BECONASE AQEQ 0.042MG DIPROP/SPRAYSPRAY, METERED / NASALRLD1987-07-27fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019389-001BECONASE AQEQ 0.042MG DIPROP/SPRAYSPRAY, METERED / NASALRLD1987-07-27b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019389-001BECONASE AQEQ 0.042MG DIPROP/SPRAYSPRAY, METERED / NASALRLD1987-07-2703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019389-001BECONASE AQEQ 0.042MG DIPROP/SPRAYSPRAY, METERED / NASALRLD1987-07-272680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019389-001BECONASE AQEQ 0.042MG DIPROP/SPRAYSPRAY, METERED / NASALRLD1987-07-275bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N019389-001BECONASE AQEQ 0.042MG DIPROP/SPRAYSPRAY, METERED / NASALRLD1987-07-27d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N019389-001BECONASE AQEQ 0.042MG DIPROP/SPRAYSPRAY, METERED / NASALRLD1987-07-27d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N019389-001BECONASE AQEQ 0.042MG DIPROP/SPRAYSPRAY, METERED / NASALRLD1987-07-2779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N019389-001BECONASE AQEQ 0.042MG DIPROP/SPRAYSPRAY, METERED / NASALRLD1987-07-27301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N019389-001BECONASE AQEQ 0.042MG DIPROP/SPRAYSPRAY, METERED / NASALRLD1987-07-271e350fbaab3a…
2024-05-31 18:47 UTC2024-05N019389-001BECONASE AQEQ 0.042MG DIPROP/SPRAYSPRAY, METERED / NASALRLD1987-07-278072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N019389-001BECONASE AQEQ 0.042MG DIPROP/SPRAYSPRAY, METERED / NASALRLD, RS1987-07-275c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N019389-001BECONASE AQEQ 0.042MG DIPROP/SPRAYSPRAY, METERED / NASALRLD, RS1987-07-275d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N019389-001BECONASE AQEQ 0.042MG DIPROP/SPRAYSPRAY, METERED / NASALRLD, RS1987-07-274b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N019389-001BECONASE AQEQ 0.042MG DIPROP/SPRAYSPRAY, METERED / NASALRLD, RS1987-07-2774a2ff9319b5…
2022-03-09 01:35 UTC2022-03N019389-001BECONASE AQEQ 0.042MG DIPROP/SPRAYSPRAY, METERED / NASALRLD, RS1987-07-27bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N019389-001BECONASE AQEQ 0.042MG DIPROP/SPRAYSPRAY, METERED / NASALRLD, RS1987-07-27782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N019389-001BECONASE AQEQ 0.042MG DIPROP/SPRAYSPRAY, METERED / NASALRLD, RS1987-07-2787673890dc5c…
2021-03-12 10:30 UTC2021-03N019389-001BECONASE AQEQ 0.042MG DIPROP/SPRAYSPRAY, METERED / NASALRLD, RS1987-07-275aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N019389-001BECONASE AQEQ 0.042MG DIPROP/SPRAYSPRAY, METERED / NASALRLD, RS1987-07-278869cabd3fbd…
2020-11-12 02:37 UTC2020-11N019389-001BECONASE AQEQ 0.042MG DIPROP/SPRAYSPRAY, METERED / NASALRLD, RS1987-07-27c0c555d07b60…
2019-12-14 00:12 UTC2019-12N019389-001BECONASE AQEQ 0.042MG DIPROP/SPRAYSPRAY, METERED / NASALRLD, RS1987-07-273f01610625f2…
2019-09-15 20:21 UTC2019-09N019389-001BECONASE AQEQ 0.042MG DIPROP/SPRAYSPRAY, METERED / NASALRLD, RS1987-07-27b00525d2431f…
2019-07-19 19:46 UTC2019-07N019389-001BECONASE AQEQ 0.042MG DIPROP/SPRAYSPRAY, METERED / NASALRLD, RS1987-07-27ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N019389-001BECONASE AQEQ 0.042MG DIPROP/SPRAYSPRAY, METERED / NASALRLD1987-07-276a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N019389-001BECONASE AQEQ 0.042MG DIPROP/SPRAYSPRAY, METERED / NASALRLD1987-07-271c564ffb4f44…
2023-12-20 04:57 UTC2023-12N019389-001BECONASE AQEQ 0.042MG DIPROP/SPRAYSPRAY, METERED / NASALRLD1987-07-27ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N019389-001BECONASE AQEQ 0.042MG DIPROP/SPRAYSPRAY, METERED / NASALRLD, RS1987-07-27a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N019389-001BECONASE AQEQ 0.042MG DIPROP/SPRAYSPRAY, METERED / NASALRLD, RS1987-07-279b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N019389-001BECONASE AQEQ 0.042MG DIPROP/SPRAYSPRAY, METERED / NASALRLD, RS1987-07-27a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N019389-001BECONASE AQEQ 0.042MG DIPROP/SPRAYSPRAY, METERED / NASALRLD, RS1987-07-273f0d92c62455…
2023-05-13 08:27 UTC2023-05N019389-001BECONASE AQEQ 0.042MG DIPROP/SPRAYSPRAY, METERED / NASALRLD, RS1987-07-27053a50430f4f…
2023-01-26 05:58 UTC2023-01N019389-001BECONASE AQEQ 0.042MG DIPROP/SPRAYSPRAY, METERED / NASALRLD, RS1987-07-273bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N019389-001BECONASE AQEQ 0.042MG DIPROP/SPRAYSPRAY, METERED / NASALRLD, RS1987-07-273a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N019389-001BECONASE AQEQ 0.042MG DIPROP/SPRAYSPRAY, METERED / NASALRLD, RS1987-07-27f41ea6bd6efb…

Reported adverse events (FAERS/openFDA)#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
56560def-9e4f-4cea-995d-33e9e282a050Product name120171204
7cc1653a-dc36-45c2-8752-61a7a3967d75Product name120170829
e97c5025-cafa-043f-50a3-771ab2b84660Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0173-0388-79GM - Gram0173-0388d0948710-cdd4-472b-babe-f0d80c12b44912012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BECLOMETHASONE DIPROPIONATE MONOHYDRATEACTIVE INGREDIENT4H7L9AI22IBECONASE AQ (BECLOMETHASONE DIPROPIONATE MONOHYDRATE) SPRAY, SUSPENSION [GLAXOSMITHKLINE LLC]10
BECLOMETHASONEACTIVE MOIETYKGZ1SLC28ZBECONASE AQ (BECLOMETHASONE DIPROPIONATE MONOHYDRATE) SPRAY, SUSPENSION [GLAXOSMITHKLINE LLC]10
BENZALKONIUM CHLORIDEINACTIVE INGREDIENTF5UM2KM3W7BECONASE AQ (BECLOMETHASONE DIPROPIONATE MONOHYDRATE) SPRAY, SUSPENSION [GLAXOSMITHKLINE LLC]10
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS311BECONASE AQ (BECLOMETHASONE DIPROPIONATE MONOHYDRATE) SPRAY, SUSPENSION [GLAXOSMITHKLINE LLC]10
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UBECONASE AQ (BECLOMETHASONE DIPROPIONATE MONOHYDRATE) SPRAY, SUSPENSION [GLAXOSMITHKLINE LLC]10
DEXTROSEINACTIVE INGREDIENTIY9XDZ35W2BECONASE AQ (BECLOMETHASONE DIPROPIONATE MONOHYDRATE) SPRAY, SUSPENSION [GLAXOSMITHKLINE LLC]10
PHENYLETHYL ALCOHOLINACTIVE INGREDIENTML9LGA7468BECONASE AQ (BECLOMETHASONE DIPROPIONATE MONOHYDRATE) SPRAY, SUSPENSION [GLAXOSMITHKLINE LLC]10
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HBECONASE AQ (BECLOMETHASONE DIPROPIONATE MONOHYDRATE) SPRAY, SUSPENSION [GLAXOSMITHKLINE LLC]10
BECLOMETHASONE DIPROPIONATE MONOHYDRATEACTIVE INGREDIENT4H7L9AI22IBECONASE (BECLOMETHASONE DIPROPIONATE MONOHYDRATE ) SPRAY, SUSPENSION [STAT RX USA LLC]3
BECLOMETHASONEACTIVE MOIETYKGZ1SLC28ZBECONASE (BECLOMETHASONE DIPROPIONATE MONOHYDRATE ) SPRAY, SUSPENSION [STAT RX USA LLC]3
BENZALKONIUM CHLORIDEINACTIVE INGREDIENTF5UM2KM3W7BECONASE (BECLOMETHASONE DIPROPIONATE MONOHYDRATE ) SPRAY, SUSPENSION [STAT RX USA LLC]3
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS311BECONASE (BECLOMETHASONE DIPROPIONATE MONOHYDRATE ) SPRAY, SUSPENSION [STAT RX USA LLC]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UBECONASE (BECLOMETHASONE DIPROPIONATE MONOHYDRATE ) SPRAY, SUSPENSION [STAT RX USA LLC]3
DEXTROSEINACTIVE INGREDIENTIY9XDZ35W2BECONASE (BECLOMETHASONE DIPROPIONATE MONOHYDRATE ) SPRAY, SUSPENSION [STAT RX USA LLC]3
PHENETHYL ALCOHOLINACTIVE INGREDIENTML9LGA7468BECONASE (BECLOMETHASONE DIPROPIONATE MONOHYDRATE ) SPRAY, SUSPENSION [STAT RX USA LLC]3
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HBECONASE (BECLOMETHASONE DIPROPIONATE MONOHYDRATE ) SPRAY, SUSPENSION [STAT RX USA LLC]3

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1797910beclomethasone dipropionate 42 MCG/ACTUAT Metered Dose Nasal SprayPSN6e8f7981-f2ca-4b56-8759-4f18cf9706c83
1797917Beconase 42 MCG/ACTUAT Metered Dose Nasal SprayPSN6e8f7981-f2ca-4b56-8759-4f18cf9706c83
1797917beclomethasone dipropionate 0.042 MG/ACTUAT Metered Dose Nasal Spray [Beconase]SBD6e8f7981-f2ca-4b56-8759-4f18cf9706c83
1797910beclomethasone dipropionate 0.042 MG/ACTUAT Metered Dose Nasal SpraySCD6e8f7981-f2ca-4b56-8759-4f18cf9706c83
1797910beclomethasone dipropionate 42 MCG/ACTUAT Metered Dose Nasal SpraySY6e8f7981-f2ca-4b56-8759-4f18cf9706c83
1797917Beconase 0.042 MG/ACTUAT Metered Dose Nasal SpraySY6e8f7981-f2ca-4b56-8759-4f18cf9706c83
1797917Beconase 42 MCG/ACTUAT Metered Dose Nasal SpraySY6e8f7981-f2ca-4b56-8759-4f18cf9706c83

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0173-0388-79001730388791 BOTTLE, PUMP in 1 CARTON (0173-0388-79) > 180 SPRAY, SUSPENSION in 1 BOTTLE, PUMP1989-10-010000-00-00NoNoCurrent