Aridol Bronchial Challenge Test Kit

Product NDC: 67850-552
11-digit product format: 678500552
Labeler code: 67850
Product ID: 67850-552_9817d443-1af2-41a9-80de-a54e3980cd7c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: mannitol
Dosage form: KIT
Labeler: Methapharm, Inc.
Application: NDA022368
Marketing category: NDA
Marketing start: 2010-10-05
Marketing end: 2027-05-31
NDC exclude flag: No
Current FDA listing: Yes

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 · 6 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
2025-02-02 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	67850-552-01	`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	67850-552-01	`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	67850-552-01	`0efc9e666f02…`	`f202fb6c5f17…`

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-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N022368-001	ARIDOL KIT	MANNITOL	N/A,5MG,10MG,20MG,40MG	POWDER / INHALATION		RLD, RS	2010-10-05

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
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N022368-001	ARIDOL KIT	N/A,5MG,10MG,20MG,40MG	POWDER / INHALATION	RLD, RS	2010-10-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022368-001	ARIDOL KIT	N/A,5MG,10MG,20MG,40MG	POWDER / INHALATION	RLD, RS	2010-10-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022368-001	ARIDOL KIT	N/A,5MG,10MG,20MG,40MG	POWDER / INHALATION	RLD, RS	2010-10-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022368-001	ARIDOL KIT	N/A,5MG,10MG,20MG,40MG	POWDER / INHALATION	RLD, RS	2010-10-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022368-001	ARIDOL KIT	N/A,5MG,10MG,20MG,40MG	POWDER / INHALATION	RLD, RS	2010-10-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022368-001	ARIDOL KIT	N/A,5MG,10MG,20MG,40MG	POWDER / INHALATION	RLD, RS	2010-10-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022368-001	ARIDOL KIT	N/A,5MG,10MG,20MG,40MG	POWDER / INHALATION	RLD, RS	2010-10-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022368-001	ARIDOL KIT	N/A,5MG,10MG,20MG,40MG	POWDER / INHALATION	RLD, RS	2010-10-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022368-001	ARIDOL KIT	N/A,5MG,10MG,20MG,40MG	POWDER / INHALATION	RLD, RS	2010-10-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022368-001	ARIDOL KIT	N/A,5MG,10MG,20MG,40MG	POWDER / INHALATION	RLD, RS	2010-10-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022368-001	ARIDOL KIT	N/A,5MG,10MG,20MG,40MG	POWDER / INHALATION	RLD, RS	2010-10-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022368-001	ARIDOL KIT	N/A,5MG,10MG,20MG,40MG	POWDER / INHALATION	RLD, RS	2010-10-05	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022368-001	ARIDOL KIT	N/A,5MG,10MG,20MG,40MG	POWDER / INHALATION	RLD, RS	2010-10-05	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022368-001	ARIDOL KIT	N/A,5MG,10MG,20MG,40MG	POWDER / INHALATION	RLD, RS	2010-10-05	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022368-001	ARIDOL KIT	N/A,5MG,10MG,20MG,40MG	POWDER / INHALATION	RLD, RS	2010-10-05	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022368-001	ARIDOL KIT	N/A,5MG,10MG,20MG,40MG	POWDER / INHALATION	RLD, RS	2010-10-05	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022368-001	ARIDOL KIT	N/A,5MG,10MG,20MG,40MG	POWDER / INHALATION	RLD, RS	2010-10-05	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022368-001	ARIDOL KIT	N/A,5MG,10MG,20MG,40MG	POWDER / INHALATION	RLD, RS	2010-10-05	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022368-001	ARIDOL KIT	N/A,5MG,10MG,20MG,40MG	POWDER / INHALATION	RLD, RS	2010-10-05	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022368-001	ARIDOL KIT	N/A,5MG,10MG,20MG,40MG	POWDER / INHALATION	RLD, RS	2010-10-05	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022368-001	ARIDOL KIT	N/A,5MG,10MG,20MG,40MG	POWDER / INHALATION	RLD, RS	2010-10-05	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022368-001	ARIDOL KIT	N/A,5MG,10MG,20MG,40MG	POWDER / INHALATION	RLD, RS	2010-10-05	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N022368-001	ARIDOL KIT	N/A,5MG,10MG,20MG,40MG	POWDER / INHALATION	RLD, RS	2010-10-05	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022368-001	ARIDOL KIT	N/A,5MG,10MG,20MG,40MG	POWDER / INHALATION	RLD, RS	2010-10-05	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N022368-001	ARIDOL KIT	N/A,5MG,10MG,20MG,40MG	POWDER / INHALATION	RLD, RS	2010-10-05	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022368-001	ARIDOL KIT	N/A,5MG,10MG,20MG,40MG	POWDER / INHALATION	RLD, RS	2010-10-05	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N022368-001	ARIDOL KIT	N/A,5MG,10MG,20MG,40MG	POWDER / INHALATION	RLD, RS	2010-10-05	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N022368-001	ARIDOL KIT	N/A,5MG,10MG,20MG,40MG	POWDER / INHALATION	RLD, RS	2010-10-05	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N022368-001	ARIDOL KIT	N/A,5MG,10MG,20MG,40MG	POWDER / INHALATION	RLD, RS	2010-10-05	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N022368-001	ARIDOL KIT	N/A,5MG,10MG,20MG,40MG	POWDER / INHALATION	RLD, RS	2010-10-05	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N022368-001	ARIDOL KIT	N/A,5MG,10MG,20MG,40MG	POWDER / INHALATION	RLD, RS	2010-10-05	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N022368-001	ARIDOL KIT	N/A,5MG,10MG,20MG,40MG	POWDER / INHALATION	RLD, RS	2010-10-05	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N022368-001	ARIDOL KIT	N/A,5MG,10MG,20MG,40MG	POWDER / INHALATION	RLD, RS	2010-10-05	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N022368-001	ARIDOL KIT	N/A,5MG,10MG,20MG,40MG	POWDER / INHALATION	RLD, RS	2010-10-05	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N022368-001	ARIDOL KIT	N/A,5MG,10MG,20MG,40MG	POWDER / INHALATION	RLD, RS	2010-10-05	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N022368-001	ARIDOL KIT	N/A,5MG,10MG,20MG,40MG	POWDER / INHALATION	RLD, RS	2010-10-05	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N022368-001	ARIDOL KIT	N/A,5MG,10MG,20MG,40MG	POWDER / INHALATION	RLD, RS	2010-10-05	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N022368-001	ARIDOL KIT	N/A,5MG,10MG,20MG,40MG	POWDER / INHALATION	RLD, RS	2010-10-05	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N022368-001	ARIDOL KIT	N/A,5MG,10MG,20MG,40MG	POWDER / INHALATION	RLD, RS	2010-10-05	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N022368-001	ARIDOL KIT	N/A,5MG,10MG,20MG,40MG	POWDER / INHALATION	RLD, RS	2010-10-05	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: Aridol Bronchial Challenge Test Kit

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
5387a4fb-b894-4cba-88a3-a947217d34da	Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
Effective	Related label
2025-02-13	These highlights do not include all the information needed to use ARIDOL safely and effectively. See full prescribing information for ARIDOL. ARIDOL ® (mannitol inhalation powder) , for oral inhalation use Bronchial Challenge Test Kit Initial U.S. Approval: 1964
2025-01-30	These highlights do not include all the information needed to use ARIDOL safely and effectively. See full prescribing information for ARIDOL. ARIDOL ® (mannitol inhalation powder) , for oral inhalation use Bronchial Challenge Test Kit Initial U.S. Approval: 1964
2023-02-13	These highlights do not include all the information needed to use ARIDOL safely and effectively. See full prescribing information for ARIDOL. ARIDOL ® (mannitol inhalation powder) , for oral inhalation use Bronchial Challenge Test Kit Initial U.S. Approval: 1964
2023-01-30	These highlights do not include all the information needed to use ARIDOL safely and effectively. See full prescribing information for ARIDOL. ARIDOL ® (mannitol inhalation powder) , for oral inhalation use Bronchial Challenge Test Kit Initial U.S. Approval: 1964

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
67850-552-01	Aridol Bronchial Challenge Test Kit	1 in 1 KIT	KIT	1		11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
67850-552-01	EA - Each	67850-552	4fb9dabc-6a01-465c-9264-cd1e42672e7d	1	2018-12-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
67850-552	ARIDOL BRONCHIAL CHALLENGE TEST KIT (MANNITOL) KIT [METHAPHARM, INC.]	10	Current NDC, Legacy NDC, 1 package rows	20250215_5387a4fb-b894-4cba-88a3-a947217d34da.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
Aridol Bronchial Challenge Test Kit	MANNITOL	Methapharm, Inc.	5387a4fb-b894-4cba-88a3-a947217d34da	2026-04-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 022368 application number: NDA022368 ndc (product): 67850-552

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
3OWL53L36A	MANNITOL	69-65-8	mannitol

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
67850-552-01	67850055201	1 KIT in 1 KIT (67850-552-01) * 1 POWDER in 1 KIT * 1 POWDER in 1 KIT * 1 POWDER in 1 CAPSULE * 1 POWDER in 1 KIT	1 kit	2010-10-05	2027-05-31	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Aridol Bronchial Challenge Test Kit - Methapharm, Inc. \| Arna Pharma Pty Ltd	Methapharm, Inc. \| Arna Pharma Pty Ltd	2026-04-23	HUMAN PRESCRIPTION DRUG LABEL	11