Acyclovir Cream, for topical use

Manufacturer: Zydus Lifesciences Limited
Effective date: 2024-08-14
Label type: HUMAN PRESCRIPTION DRUG LABEL
Version: 2
Source: full-release
Hydrated at: 2026-05-31 21:10:45

Label at a glance#

ProductAcyclovir

Active ingredientACYCLOVIR

Label structure1 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1808-5 in tube of 5 g

Acyclovir Cream, 5%

Rx only

2 g

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
141859	acyclovir 5 % Topical Cream	PSN	2
141859	acyclovir 50 MG/ML Topical Cream	SCD	2
141859	acyclovir 5 % Topical Cream	SY	2
141859	acycycloguanosine 50 MG/ML Topical Cream	SY	2

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
70771-1808-2	Acyclovir	1 in 1 CARTON	CREAM	1	2
70771-1808-2	Acyclovir	2 g in 1 TUBE	CREAM	2	2
70771-1808-5	Acyclovir	5 g in 1 TUBE	CREAM	5	2
70771-1808-5	Acyclovir	1 in 1 CARTON	CREAM	1	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70771-1808	ACYCLOVIR CREAM [ZYDUS LIFESCIENCES LIMITED]	2	Current NDC, 4 package rows	20240817_bb956f2b-627a-49bd-b258-4aac21d64b9a.zip

Products#

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

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

Acyclovir
CETOSTEARYL ALCOHOL
MINERAL OIL
PETROLATUM
POLOXAMER 407
PROPYLENE GLYCOL
SODIUM LAURYL SULFATE
WATER

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
70771-1808	70771-1808-2, 70771-1808-5

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
ACYCLOVIR	X4HES1O11F	ACTIB
CETOSTEARYL ALCOHOL	2DMT128M1S	IACT
MINERAL OIL	T5L8T28FGP	IACT
PETROLATUM	4T6H12BN9U	IACT
POLOXAMER 407	TUF2IVW3M2	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
SODIUM LAURYL SULFATE	368GB5141J	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
A206770-001	ACYCLOVIR	ACYCLOVIR	5%	CREAM / TOPICAL	BX		2023-02-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A206770-001	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	A206770-001	ACYCLOVIR	5%	CREAM / TOPICAL	BX	2023-02-28	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A206770-001	ACYCLOVIR	5%	CREAM / TOPICAL	BX	2023-02-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A206770-001	ACYCLOVIR	5%	CREAM / TOPICAL	BX	2023-02-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206770-001	ACYCLOVIR	5%	CREAM / TOPICAL	BX	2023-02-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206770-001	ACYCLOVIR	5%	CREAM / TOPICAL	BX	2023-02-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206770-001	ACYCLOVIR	5%	CREAM / TOPICAL	AB	2023-02-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206770-001	ACYCLOVIR	5%	CREAM / TOPICAL	AB	2023-02-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206770-001	ACYCLOVIR	5%	CREAM / TOPICAL	AB	2023-02-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206770-001	ACYCLOVIR	5%	CREAM / TOPICAL	AB	2023-02-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206770-001	ACYCLOVIR	5%	CREAM / TOPICAL	AB	2023-02-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206770-001	ACYCLOVIR	5%	CREAM / TOPICAL	AB	2023-02-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206770-001	ACYCLOVIR	5%	CREAM / TOPICAL	AB	2023-02-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206770-001	ACYCLOVIR	5%	CREAM / TOPICAL	AB	2023-02-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206770-001	ACYCLOVIR	5%	CREAM / TOPICAL	AB	2023-02-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206770-001	ACYCLOVIR	5%	CREAM / TOPICAL	AB	2023-02-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206770-001	ACYCLOVIR	5%	CREAM / TOPICAL	AB	2023-02-28	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A206770-001	ACYCLOVIR	5%	CREAM / TOPICAL	AB	2023-02-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A206770-001	ACYCLOVIR	5%	CREAM / TOPICAL	AB	2023-02-28	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A206770-001	ACYCLOVIR	5%	CREAM / TOPICAL	AB	2023-02-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A206770-001	ACYCLOVIR	5%	CREAM / TOPICAL	AB	2023-02-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A206770-001	ACYCLOVIR	5%	CREAM / TOPICAL	AB	2023-02-28	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A206770-001	ACYCLOVIR	5%	CREAM / TOPICAL	AB	2023-02-28	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A206770-001	ACYCLOVIR	5%	CREAM / TOPICAL	AB	2023-02-28	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A206770-001	ACYCLOVIR	5%	CREAM / TOPICAL	AB	2023-02-28	`053a50430f4f…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A206770-001	ACYCLOVIR	5%	CREAM / TOPICAL	BX	2023-02-28	`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	A206770-001	BX	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A206770-001	BX	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A206770-001	BX	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206770-001	BX	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206770-001	BX	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206770-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206770-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206770-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206770-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206770-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206770-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206770-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206770-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206770-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206770-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206770-001	AB	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A206770-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A206770-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A206770-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A206770-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A206770-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A206770-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A206770-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A206770-001	AB	1	`053a50430f4f…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A206770-001	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
Acyclovir	ACYCLOVIR	Zydus Lifesciences Limited	bb956f2b-627a-49bd-b258-4aac21d64b9a	2024-08-14		Exact identifier ndc (package): 70771-1808-2 ndc (package): 70771-1808-5 ndc (product): 70771-1808 ndc11 (package): 70771180802 ndc11 (package): 70771180805 spl id: 400d6da5-8a57-4156-a3ef-4aaacfe2d7ef spl set id: bb956f2b-627a-49bd-b258-4aac21d64b9a

Reported adverse events (FAERS/openFDA)#

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