Metronidazole Topical Cream, 0.75%

Manufacturer: Zydus Lifesciences Limited
Effective date: 2023-05-05
Label type: HUMAN PRESCRIPTION DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-05-31 20:49:45

Label at a glance#

ProductMetronidazole

Active ingredientMETRONIDAZOLE

Label structure1 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1834-4

Metronidazole Topical Cream, 0.75%

Rx only

45 g

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
311678	metroNIDAZOLE 0.75 % Topical Cream	PSN	1
311678	metronidazole 7.5 MG/ML Topical Cream	SCD	1
311678	metronidazole 0.75 % Topical Cream	SY	1

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
METRONIDAZOLE Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
8ffb9b1d-3ed7-ba2e-677e-47d4d134fd55	Product name	5	20251024
7f6d14e0-4366-41bc-a4a9-b74c79a20e17	Product name	1	20250623
e6d321b0-0e5e-7da6-f043-92b6a91f00a1	Product name	5	20250515
e1aac33b-94ae-4ee9-905b-299f7263853b	Product name	3	20250124
16642716-d28a-4f90-8dcb-3921cd8c8109	Product name	4	20240516
0be8e4ae-4d57-49f3-b3a9-e4728b4e8d15	Product name	1	20240313
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029
444b3e50-f226-46ef-bfca-2e7035d140cd	Product name	1	20190611
dea2eded-d1e7-46bb-9a3d-f8dc20de6277	Product name	1	20190408
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
a5070875-62bb-61e1-fd46-8f7054197a40	Product name	8	20180215
0add4de9-d152-3375-3390-1123dddc5e3d	Product name	1	20140508
33ca0fcc-1011-92dc-50a9-a383683eed1e	Product name	1	20140508
53f39d9f-cd3f-04e1-c668-d4580719d57d	Product name	1	20140508
597b1cfd-7b31-5048-62be-ca5cd740da2f	Product name	1	20140508
a804000f-b74f-0b5d-d17b-aa767c286ddb	Product name	1	20140508
a91ea265-6e02-c08f-93c8-686d54180529	Product name	1	20140508
ec2149b3-5c6d-5344-f757-c86411073075	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
70771-1834-4	Metronidazole	1 in 1 CARTON	CREAM	1		1
70771-1834-4	Metronidazole	45 g in 1 TUBE	CREAM	45		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70771-1834	METRONIDAZOLE CREAM [ZYDUS LIFESCIENCES LIMITED]	1	Current NDC, 2 package rows	20230531_728ebe6d-7a20-481d-845a-ceffa450179f.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 8 matching rows.

Metronidazole
BENZYL ALCOHOL
GLYCERIN
ISOPROPYL PALMITATE
LACTIC ACID
SODIUM HYDROXIDE
SORBITOL SOLUTION
WATER

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
70771-1834	70771-1834-4

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
METRONIDAZOLE	140QMO216E	ACTIB
BENZYL ALCOHOL	LKG8494WBH	IACT
GLYCERIN	PDC6A3C0OX	IACT
ISOPROPYL PALMITATE	8CRQ2TH63M	IACT
LACTIC ACID	33X04XA5AT	IACT
SODIUM HYDROXIDE	55X04QC32I	IACT
SORBITOL SOLUTION	8KW3E207O2	IACT
WATER	059QF0KO0R	IACT

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

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-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A217128-001	METRONIDAZOLE	METRONIDAZOLE	0.75%	CREAM / TOPICAL	BX		2023-04-21

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A217128-001	BX

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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A217128-001	METRONIDAZOLE	0.75%	CREAM / TOPICAL	BX	2023-04-21	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A217128-001	METRONIDAZOLE	0.75%	CREAM / TOPICAL	BX	2023-04-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A217128-001	METRONIDAZOLE	0.75%	CREAM / TOPICAL	BX	2023-04-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217128-001	METRONIDAZOLE	0.75%	CREAM / TOPICAL	BX	2023-04-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A217128-001	METRONIDAZOLE	0.75%	CREAM / TOPICAL	BX	2023-04-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217128-001	METRONIDAZOLE	0.75%	CREAM / TOPICAL	AB	2023-04-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217128-001	METRONIDAZOLE	0.75%	CREAM / TOPICAL	AB	2023-04-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217128-001	METRONIDAZOLE	0.75%	CREAM / TOPICAL	AB	2023-04-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217128-001	METRONIDAZOLE	0.75%	CREAM / TOPICAL	AB	2023-04-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217128-001	METRONIDAZOLE	0.75%	CREAM / TOPICAL	AB	2023-04-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217128-001	METRONIDAZOLE	0.75%	CREAM / TOPICAL	AB	2023-04-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A217128-001	METRONIDAZOLE	0.75%	CREAM / TOPICAL	AB	2023-04-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217128-001	METRONIDAZOLE	0.75%	CREAM / TOPICAL	AB	2023-04-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A217128-001	METRONIDAZOLE	0.75%	CREAM / TOPICAL	AB	2023-04-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A217128-001	METRONIDAZOLE	0.75%	CREAM / TOPICAL	AB	2023-04-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A217128-001	METRONIDAZOLE	0.75%	CREAM / TOPICAL	AB	2023-04-21	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A217128-001	METRONIDAZOLE	0.75%	CREAM / TOPICAL	AB	2023-04-21	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A217128-001	METRONIDAZOLE	0.75%	CREAM / TOPICAL	AB	2023-04-21	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A217128-001	METRONIDAZOLE	0.75%	CREAM / TOPICAL	AB	2023-04-21	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A217128-001	METRONIDAZOLE	0.75%	CREAM / TOPICAL	AB	2023-04-21	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A217128-001	METRONIDAZOLE	0.75%	CREAM / TOPICAL	AB	2023-04-21	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A217128-001	METRONIDAZOLE	0.75%	CREAM / TOPICAL	AB	2023-04-21	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A217128-001	METRONIDAZOLE	0.75%	CREAM / TOPICAL	AB	2023-04-21	`3f0d92c62455…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A217128-001	METRONIDAZOLE	0.75%	CREAM / TOPICAL	BX	2023-04-21	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A217128-001	BX	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A217128-001	BX	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A217128-001	BX	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217128-001	BX	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A217128-001	BX	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217128-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217128-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217128-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217128-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217128-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217128-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A217128-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217128-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A217128-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A217128-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A217128-001	AB	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A217128-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A217128-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A217128-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A217128-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A217128-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A217128-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A217128-001	AB	1	`3f0d92c62455…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A217128-001	BX	1	`a50c72e98297…`

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	Zydus Lifesciences Limited	728ebe6d-7a20-481d-845a-ceffa450179f	2023-05-05		Exact identifier ndc (package): 70771-1834-4 ndc (product): 70771-1834 ndc11 (package): 70771183404 spl id: bac9d2c8-3d87-4ec8-aa22-760d3c66440b spl set id: 728ebe6d-7a20-481d-845a-ceffa450179f

Reported adverse events (FAERS/openFDA)#

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