Acyclovir Ointment USP, 5%

Manufacturer: Zydus Lifesciences Limited
Effective date: 2024-08-14
Label type: HUMAN PRESCRIPTION DRUG LABEL
Version: 4
Source: full-release
Hydrated at: 2026-05-31 21:10:46

Label at a glance#

Productacyclovir

Active ingredientACYCLOVIR

Label structure1 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Acyclovir Ointment USP, 5%

NDC 70771-1371-1 in tube of 15 gm

Rx Only

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
197312	acyclovir 5 % Topical Ointment	PSN	4
197312	acyclovir 0.05 MG/MG Topical Ointment	SCD	4
197312	acyclovir 5 % Topical Ointment	SY	4
197312	acyclovir 50 MG per 1 GM Topical Ointment	SY	4
197312	acycycloguanosine 0.05 MG/MG Topical Ointment	SY	4

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
ACYCLOVIR Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20181113

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
33190c02-82e1-0a4d-d716-9ccd23588463	Product name	5	20250225
c367d1da-5a72-8966-6d11-1eb9a73ae758	Product name	3	20231115
5518bf13-db2f-2e9c-3679-e70ecf03752c	Product name	9	20210614
27897900-0e40-497b-97e1-88057e68fe6c	Product name	4	20200710
ca834e59-e669-229c-9288-0ccb76dc373e	Product name	9	20200220
d7f95c49-d3e1-4bbc-a389-e9cd73f59a28	Product name	1	20190702
fb15b394-3715-4c87-a447-421489aa8739	Product name	3	20170727
7bdc4804-3832-c0df-e519-72b6d47c9792	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
70771-1371-1	acyclovir	1 in 1 CARTON	OINTMENT	1	4
70771-1371-1	acyclovir	15 g in 1 TUBE	OINTMENT	15	4
70771-1371-2	acyclovir	30 g in 1 TUBE	OINTMENT	30	4
70771-1371-2	acyclovir	1 in 1 CARTON	OINTMENT	1	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70771-1371	ACYCLOVIR OINTMENT [ZYDUS LIFESCIENCES LIMITED]	4	Current NDC, Legacy NDC, 4 package rows	20240817_fdf6b492-a76e-4cea-89a1-a5b19c7938ff.zip

Products#

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

DailyMed product names page 1 of 1 · 2 matching rows.

acyclovir
POLYETHYLENE GLYCOL, UNSPECIFIED

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
70771-1371	70771-1371-1, 70771-1371-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
ACYCLOVIR	X4HES1O11F	ACTIB
POLYETHYLENE GLYCOL, UNSPECIFIED	3WJQ0SDW1A	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
A205974-001	ACYCLOVIR	ACYCLOVIR	5%	OINTMENT / TOPICAL	AB		2019-03-15

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A205974-001	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 · 43 observed 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	A205974-001	ACYCLOVIR	5%	OINTMENT / TOPICAL	AB	2019-03-15	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A205974-001	ACYCLOVIR	5%	OINTMENT / TOPICAL	AB	2019-03-15	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A205974-001	ACYCLOVIR	5%	OINTMENT / TOPICAL	AB	2019-03-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205974-001	ACYCLOVIR	5%	OINTMENT / TOPICAL	AB	2019-03-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205974-001	ACYCLOVIR	5%	OINTMENT / TOPICAL	AB	2019-03-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205974-001	ACYCLOVIR	5%	OINTMENT / TOPICAL	AB	2019-03-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205974-001	ACYCLOVIR	5%	OINTMENT / TOPICAL	AB	2019-03-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205974-001	ACYCLOVIR	5%	OINTMENT / TOPICAL	AB	2019-03-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205974-001	ACYCLOVIR	5%	OINTMENT / TOPICAL	AB	2019-03-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205974-001	ACYCLOVIR	5%	OINTMENT / TOPICAL	AB	2019-03-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205974-001	ACYCLOVIR	5%	OINTMENT / TOPICAL	AB	2019-03-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205974-001	ACYCLOVIR	5%	OINTMENT / TOPICAL	AB	2019-03-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205974-001	ACYCLOVIR	5%	OINTMENT / TOPICAL	AB	2019-03-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205974-001	ACYCLOVIR	5%	OINTMENT / TOPICAL	AB	2019-03-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205974-001	ACYCLOVIR	5%	OINTMENT / TOPICAL	AB	2019-03-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205974-001	ACYCLOVIR	5%	OINTMENT / TOPICAL	AB	2019-03-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205974-001	ACYCLOVIR	5%	OINTMENT / TOPICAL	AB	2019-03-15	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A205974-001	ACYCLOVIR	5%	OINTMENT / TOPICAL	AB	2019-03-15	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A205974-001	ACYCLOVIR	5%	OINTMENT / TOPICAL	AB	2019-03-15	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A205974-001	ACYCLOVIR	5%	OINTMENT / TOPICAL	AB	2019-03-15	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A205974-001	ACYCLOVIR	5%	OINTMENT / TOPICAL	AB	2019-03-15	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A205974-001	ACYCLOVIR	5%	OINTMENT / TOPICAL	AB	2019-03-15	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A205974-001	ACYCLOVIR	5%	OINTMENT / TOPICAL	AB	2019-03-15	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A205974-001	ACYCLOVIR	5%	OINTMENT / TOPICAL	AB	2019-03-15	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A205974-001	ACYCLOVIR	5%	OINTMENT / TOPICAL	AB	2019-03-15	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A205974-001	ACYCLOVIR	5%	OINTMENT / TOPICAL	AB	2019-03-15	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A205974-001	ACYCLOVIR	5%	OINTMENT / TOPICAL	AB	2019-03-15	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A205974-001	ACYCLOVIR	5%	OINTMENT / TOPICAL	AB	2019-03-15	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A205974-001	ACYCLOVIR	5%	OINTMENT / TOPICAL	AB	2019-03-15	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A205974-001	ACYCLOVIR	5%	OINTMENT / TOPICAL	AB	2019-03-15	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A205974-001	ACYCLOVIR	5%	OINTMENT / TOPICAL	AB	2019-03-15	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A205974-001	ACYCLOVIR	5%	OINTMENT / TOPICAL	AB	2019-03-15	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A205974-001	ACYCLOVIR	5%	OINTMENT / TOPICAL	AB	2019-03-15	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A205974-001	ACYCLOVIR	5%	OINTMENT / TOPICAL	AB	2019-03-15	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A205974-001	ACYCLOVIR	5%	OINTMENT / TOPICAL	AB	2019-03-15	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A205974-001	ACYCLOVIR	5%	OINTMENT / TOPICAL	AB	2019-03-15	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A205974-001	ACYCLOVIR	5%	OINTMENT / TOPICAL	AB	2019-03-15	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A205974-001	ACYCLOVIR	5%	OINTMENT / TOPICAL	AB	2019-03-15	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A205974-001	ACYCLOVIR	5%	OINTMENT / TOPICAL	AB	2019-03-15	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A205974-001	ACYCLOVIR	5%	OINTMENT / TOPICAL	AB	2019-03-15	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A205974-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A205974-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A205974-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205974-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205974-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205974-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205974-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205974-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205974-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205974-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205974-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205974-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205974-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205974-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205974-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205974-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205974-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A205974-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A205974-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A205974-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A205974-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A205974-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A205974-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A205974-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A205974-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A205974-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A205974-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A205974-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A205974-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A205974-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A205974-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A205974-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A205974-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A205974-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A205974-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A205974-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A205974-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A205974-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A205974-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A205974-001	AB	1	`f41ea6bd6efb…`

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
acyclovir	ACYCLOVIR	Zydus Lifesciences Limited	fdf6b492-a76e-4cea-89a1-a5b19c7938ff	2024-08-14		Exact identifier ndc (package): 70771-1371-2 ndc (package): 70771-1371-1 ndc (product): 70771-1371 ndc11 (package): 70771137101 ndc11 (package): 70771137102 spl id: ed4f7f52-6254-46ad-8be4-e830705bbcfa spl set id: fdf6b492-a76e-4cea-89a1-a5b19c7938ff

Reported adverse events (FAERS/openFDA)#

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