metronidazole

Product NDC: 66993-961
11-digit product format: 669930961
Labeler code: 66993
Product ID: 66993-961_10c57390-98b0-4a9f-8f8d-8d4eb9d16401
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: metronidazole
Dosage form: LOTION
Route: TOPICAL
Labeler: Prasco Laboratories
Application: NDA020901
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 2009-05-28
Marketing end: 0000-00-00
Substance: METRONIDAZOLE
Active strength: 8 mg/g
Pharmacologic classes: Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [CS]
NDC exclude flag: No
Listing certified through: 2020-12-31
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
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	66993-961		D	Discontinued by firm		2026-08-10
excluded package	package	66993-961	66993-961-59	D	Discontinued by firm		2026-08-10

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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product	66993-961		D	Discontinued by firm		excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	66993-961	66993-961-59	D	Discontinued by firm		excluded / ndc_excluded.zip	`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
N020901-001	METROLOTION	METRONIDAZOLE	0.75%	LOTION / TOPICAL	AB	RLD, RS	1998-11-24

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
N020901-001	AB

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	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N020901-001	METROLOTION	0.75%	LOTION / TOPICAL	AB	RLD, RS	1998-11-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020901-001	METROLOTION	0.75%	LOTION / TOPICAL	AB	RLD, RS	1998-11-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020901-001	METROLOTION	0.75%	LOTION / TOPICAL	AB	RLD, RS	1998-11-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020901-001	METROLOTION	0.75%	LOTION / TOPICAL	AB	RLD, RS	1998-11-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020901-001	METROLOTION	0.75%	LOTION / TOPICAL	AB	RLD, RS	1998-11-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020901-001	METROLOTION	0.75%	LOTION / TOPICAL	AB	RLD, RS	1998-11-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020901-001	METROLOTION	0.75%	LOTION / TOPICAL	AB	RLD, RS	1998-11-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020901-001	METROLOTION	0.75%	LOTION / TOPICAL	AB	RLD, RS	1998-11-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020901-001	METROLOTION	0.75%	LOTION / TOPICAL	AB	RLD, RS	1998-11-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020901-001	METROLOTION	0.75%	LOTION / TOPICAL	AB	RLD, RS	1998-11-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020901-001	METROLOTION	0.75%	LOTION / TOPICAL	AB	RLD, RS	1998-11-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020901-001	METROLOTION	0.75%	LOTION / TOPICAL	AB	RLD, RS	1998-11-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020901-001	METROLOTION	0.75%	LOTION / TOPICAL	AB	RLD, RS	1998-11-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020901-001	METROLOTION	0.75%	LOTION / TOPICAL	AB	RLD, RS	1998-11-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020901-001	METROLOTION	0.75%	LOTION / TOPICAL	AB	RLD, RS	1998-11-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020901-001	METROLOTION	0.75%	LOTION / TOPICAL	AB	RLD, RS	1998-11-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020901-001	METROLOTION	0.75%	LOTION / TOPICAL	AB	RLD, RS	1998-11-24	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020901-001	METROLOTION	0.75%	LOTION / TOPICAL	AB	RLD, RS	1998-11-24	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020901-001	METROLOTION	0.75%	LOTION / TOPICAL	AB	RLD, RS	1998-11-24	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020901-001	METROLOTION	0.75%	LOTION / TOPICAL	AB	RLD, RS	1998-11-24	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020901-001	METROLOTION	0.75%	LOTION / TOPICAL	AB	RLD, RS	1998-11-24	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020901-001	METROLOTION	0.75%	LOTION / TOPICAL	AB	RLD, RS	1998-11-24	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020901-001	METROLOTION	0.75%	LOTION / TOPICAL	AB	RLD, RS	1998-11-24	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020901-001	METROLOTION	0.75%	LOTION / TOPICAL	AB	RLD, RS	1998-11-24	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020901-001	METROLOTION	0.75%	LOTION / TOPICAL	AB	RLD, RS	1998-11-24	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020901-001	METROLOTION	0.75%	LOTION / TOPICAL	AB	RLD, RS	1998-11-24	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020901-001	METROLOTION	0.75%	LOTION / TOPICAL	AB	RLD, RS	1998-11-24	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020901-001	METROLOTION	0.75%	LOTION / TOPICAL	AB	RLD, RS	1998-11-24	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020901-001	METROLOTION	0.75%	LOTION / TOPICAL	AB	RLD, RS	1998-11-24	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020901-001	METROLOTION	0.75%	LOTION / TOPICAL	AB	RLD, RS	1998-11-24	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020901-001	METROLOTION	0.75%	LOTION / TOPICAL	AB	RLD, RS	1998-11-24	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020901-001	METROLOTION	0.75%	LOTION / TOPICAL	AB	RLD, RS	1998-11-24	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020901-001	METROLOTION	0.75%	LOTION / TOPICAL	AB	RLD, RS	1998-11-24	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020901-001	METROLOTION	0.75%	LOTION / TOPICAL	AB	RLD, RS	1998-11-24	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020901-001	METROLOTION	0.75%	LOTION / TOPICAL	AB	RLD, RS	1998-11-24	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020901-001	METROLOTION	0.75%	LOTION / TOPICAL	AB	RLD, RS	1998-11-24	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020901-001	METROLOTION	0.75%	LOTION / TOPICAL	AB	RLD, RS	1998-11-24	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N020901-001	METROLOTION	0.75%	LOTION / TOPICAL	AB	RLD, RS	1998-11-24	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N020901-001	METROLOTION	0.75%	LOTION / TOPICAL	AB	RLD, RS	1998-11-24	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N020901-001	METROLOTION	0.75%	LOTION / TOPICAL	AB	RLD, RS	1998-11-24	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N020901-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020901-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020901-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020901-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020901-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020901-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020901-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020901-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020901-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020901-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020901-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020901-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020901-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020901-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020901-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020901-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020901-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020901-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020901-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020901-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020901-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020901-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020901-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020901-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020901-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020901-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020901-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020901-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020901-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020901-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020901-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020901-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020901-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020901-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020901-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020901-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020901-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N020901-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N020901-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N020901-001	AB	1	`cb3db0bc1861…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
66993-961-59	ML - Milliliter	66993-961	57a28db2-4eaf-4e0c-835a-fdc38c6ec54f	1	2014-02-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
METRONIDAZOLE	ACTIVE INGREDIENT	140QMO216E	METRONIDAZOLE LOTION [PRASCO LABORATORIES]	2
METRONIDAZOLE	ACTIVE MOIETY	140QMO216E	METRONIDAZOLE LOTION [PRASCO LABORATORIES]	2
BENZYL ALCOHOL	INACTIVE INGREDIENT	LKG8494WBH	METRONIDAZOLE LOTION [PRASCO LABORATORIES]	2
CARBOMER HOMOPOLYMER TYPE A	INACTIVE INGREDIENT	F68VH75CJC	METRONIDAZOLE LOTION [PRASCO LABORATORIES]	2
CYCLOMETHICONE	INACTIVE INGREDIENT	NMQ347994Z	METRONIDAZOLE LOTION [PRASCO LABORATORIES]	2
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	METRONIDAZOLE LOTION [PRASCO LABORATORIES]	2
GLYCERYL MONOSTEARATE	INACTIVE INGREDIENT	230OU9XXE4	METRONIDAZOLE LOTION [PRASCO LABORATORIES]	2
LACTIC ACID	INACTIVE INGREDIENT	33X04XA5AT	METRONIDAZOLE LOTION [PRASCO LABORATORIES]	2
LIGHT MINERAL OIL	INACTIVE INGREDIENT	N6K5787QVP	METRONIDAZOLE LOTION [PRASCO LABORATORIES]	2
PEG-100 STEARATE	INACTIVE INGREDIENT	YD01N1999R	METRONIDAZOLE LOTION [PRASCO LABORATORIES]	2
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	METRONIDAZOLE LOTION [PRASCO LABORATORIES]	2
POTASSIUM SORBATE	INACTIVE INGREDIENT	1VPU26JZZ4	METRONIDAZOLE LOTION [PRASCO LABORATORIES]	2
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	METRONIDAZOLE LOTION [PRASCO LABORATORIES]	2
STEARETH-21	INACTIVE INGREDIENT	53J3F32P58	METRONIDAZOLE LOTION [PRASCO LABORATORIES]	2
STEARYL ALCOHOL	INACTIVE INGREDIENT	2KR89I4H1Y	METRONIDAZOLE LOTION [PRASCO LABORATORIES]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	METRONIDAZOLE LOTION [PRASCO LABORATORIES]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
66993-961	METRONIDAZOLE LOTION [PRASCO LABORATORIES]	6	Legacy NDC	20250119_fce3e59e-8e08-47f1-947f-5a6d141ba1b2.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
metronidazole	METRONIDAZOLE	Mayne Pharma Inc.	5099691f-f216-4ac1-b057-99a845cc770f	2024-09-30	Adverse reactions	Exact identifier application applno (NDA): 020901 application number: NDA020901

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
140QMO216E	METRONIDAZOLE	443-48-1	METRONIDAZOLE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
66993-961-59	66993096159	1 BOTTLE in 1 CARTON (66993-961-59) > 59.7 g in 1 BOTTLE	1 bottle	2009-05-28	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Metronidazole Topical Lotion, 0.75% Rx only FOR TOPICAL USE ONLY (NOT FOR OPHTHALMIC USE)	Prasco Laboratories \| DPT Laboratories, Ltd. \| G Production Inc.	2025-01-15	HUMAN PRESCRIPTION DRUG LABEL	6