erythromycin

Product NDC: 42571-384
Requested package NDC: 42571-384-25
11-digit product format: 425710384
Labeler code: 42571
Product ID: 42571-384_ef68c009-7789-4c11-82e3-4200b9469987
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: erythromycin
Dosage form: SOLUTION
Route: TOPICAL
Labeler: MICRO LABS LIMITED
Application: ANDA062687
Marketing category: ANDA
Marketing start: 2021-06-04
Marketing end: 0000-00-00
Substance: ERYTHROMYCIN
Active strength: 20 mg/mL
Pharmacologic classes: Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]
NDC exclude flag: No
Listing certified through: 2023-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	42571-384	42571-384-25	I	Inactivated by FDA		2026-08-10

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
A062687-001	ERYTHRA-DERM	ERYTHROMYCIN	2%	SOLUTION / TOPICAL	AT		1988-02-05

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A062687-001	AT

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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A062687-001	ERYTHRA-DERM	2%	SOLUTION / TOPICAL	AT	1988-02-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062687-001	ERYTHRA-DERM	2%	SOLUTION / TOPICAL	AT	1988-02-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A062687-001	ERYTHRA-DERM	2%	SOLUTION / TOPICAL	AT	1988-02-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062687-001	ERYTHRA-DERM	2%	SOLUTION / TOPICAL	AT	1988-02-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062687-001	ERYTHRA-DERM	2%	SOLUTION / TOPICAL	AT	1988-02-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062687-001	ERYTHRA-DERM	2%	SOLUTION / TOPICAL	AT	1988-02-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062687-001	ERYTHRA-DERM	2%	SOLUTION / TOPICAL	AT	1988-02-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062687-001	ERYTHRA-DERM	2%	SOLUTION / TOPICAL	AT	1988-02-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062687-001	ERYTHRA-DERM	2%	SOLUTION / TOPICAL	AT	1988-02-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A062687-001	ERYTHRA-DERM	2%	SOLUTION / TOPICAL	AT	1988-02-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062687-001	ERYTHRA-DERM	2%	SOLUTION / TOPICAL	AT	1988-02-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062687-001	ERYTHRA-DERM	2%	SOLUTION / TOPICAL	AT	1988-02-05	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062687-001	ERYTHRA-DERM	2%	SOLUTION / TOPICAL	AT	1988-02-05	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A062687-001	ERYTHRA-DERM	2%	SOLUTION / TOPICAL	AT	1988-02-05	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A062687-001	ERYTHRA-DERM	2%	SOLUTION / TOPICAL	AT	1988-02-05	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A062687-001	ERYTHRA-DERM	2%	SOLUTION / TOPICAL	AT	1988-02-05	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A062687-001	ERYTHRA-DERM	2%	SOLUTION / TOPICAL	AT	1988-02-05	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A062687-001	ERYTHRA-DERM	2%	SOLUTION / TOPICAL		1988-02-05	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A062687-001	ERYTHRA-DERM	2%	SOLUTION / TOPICAL	AT	1988-02-05	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A062687-001	ERYTHRA-DERM	2%	SOLUTION / TOPICAL	AT	1988-02-05	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A062687-001	ERYTHRA-DERM	2%	SOLUTION / TOPICAL		1988-02-05	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A062687-001	ERYTHRA-DERM	2%	SOLUTION / TOPICAL		1988-02-05	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A062687-001	ERYTHRA-DERM	2%	SOLUTION / TOPICAL		1988-02-05	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A062687-001	ERYTHRA-DERM	2%	SOLUTION / TOPICAL		1988-02-05	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A062687-001	ERYTHRA-DERM	2%	SOLUTION / TOPICAL		1988-02-05	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A062687-001	ERYTHRA-DERM	2%	SOLUTION / TOPICAL		1988-02-05	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A062687-001	ERYTHRA-DERM	2%	SOLUTION / TOPICAL		1988-02-05	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A062687-001	ERYTHRA-DERM	2%	SOLUTION / TOPICAL	AT	1988-02-05	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A062687-001	ERYTHRA-DERM	2%	SOLUTION / TOPICAL	AT	1988-02-05	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A062687-001	ERYTHRA-DERM	2%	SOLUTION / TOPICAL	AT	1988-02-05	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A062687-001	ERYTHRA-DERM	2%	SOLUTION / TOPICAL	AT	1988-02-05	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A062687-001	ERYTHRA-DERM	2%	SOLUTION / TOPICAL	AT	1988-02-05	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A062687-001	ERYTHRA-DERM	2%	SOLUTION / TOPICAL	AT	1988-02-05	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A062687-001	ERYTHRA-DERM	2%	SOLUTION / TOPICAL	AT	1988-02-05	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A062687-001	ERYTHRA-DERM	2%	SOLUTION / TOPICAL	AT	1988-02-05	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A062687-001	ERYTHRA-DERM	2%	SOLUTION / TOPICAL	AT	1988-02-05	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A062687-001	ERYTHRA-DERM	2%	SOLUTION / TOPICAL	AT	1988-02-05	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A062687-001	ERYTHRA-DERM	2%	SOLUTION / TOPICAL	AT	1988-02-05	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A062687-001	ERYTHRA-DERM	2%	SOLUTION / TOPICAL	AT	1988-02-05	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A062687-001	ERYTHRA-DERM	2%	SOLUTION / TOPICAL	AT	1988-02-05	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A062687-001	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062687-001	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A062687-001	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062687-001	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062687-001	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062687-001	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062687-001	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062687-001	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062687-001	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A062687-001	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062687-001	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062687-001	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062687-001	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A062687-001	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A062687-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A062687-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A062687-001	AT	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A062687-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A062687-001	AT	1	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A062687-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A062687-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A062687-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A062687-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A062687-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A062687-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A062687-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A062687-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A062687-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A062687-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A062687-001	AT	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A062687-001	AT	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A062687-001	AT	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A062687-001	AT	1	`a50c72e98297…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
d329c2e1-5ae8-4e64-aea0-77ecea3fa1ab	Product name	3	20250717
3b331500-3b74-bd2b-fede-d46839f2f4d5	Product name	6	20240313
fdae2630-eae0-4769-abfd-8f33d5b771b4	Product name	3	20240202
e2db08c6-133f-4f4f-afb4-e90a2418d6f6	Product name	1	20230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906	Product name	7	20210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029
8c898317-b543-1e4e-254f-84cec2f3f57e	Product name	2	20191002
11ed6f83-cdd2-4637-8379-b1a1d3ae3cde	Product name	1	20181101
7792dadb-52b6-46b6-8fdf-80b1171065b5	Product name	1	20180810
86c45a79-b9f0-4476-a27c-6e10db098497	Product name	1	20180125
64ae94c0-3212-d73a-92da-9e6dd85c6ebe	Product name	2	20180118
edcfa1cf-915f-1a4c-d0aa-508cc66e70d9	Product name	2	20170816
ad75fcfd-a339-42a1-9c60-43ba2c654cfa	Product name	1	20170810
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
57850177-5927-151f-e1fa-7e2ca47f81e5	Product name	1	20140508
8ee71591-1d8f-e24e-242b-bfef131e3168	Product name	1	20140508
bff5cf99-0f45-fa15-2a76-b160c3c4cc3c	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
42571-384-25	erythromycin	1 in 1 CARTON	SOLUTION	1		3
42571-384-25	erythromycin	60 mL in 1 BOTTLE	SOLUTION	60		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
42571-384-25	ML - Milliliter	42571-384	773d00bf-df21-4a74-9f9d-af16da0d4ce2	1	2021-07-15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
42571-384	ERYTHROMYCIN SOLUTION [MICRO LABS LIMITED]	3	Legacy NDC, 2 package rows	20241228_05cf40f6-1cef-42ea-8213-062880ce5aa2.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
erythromycin topical solution 2%	ERYTHROMYCIN TOPICAL SOLUTION 2%	Saptalis Pharmaceuticals, LLC LLC	21b64a3f-2c95-1c1a-e063-6294a90a0ea0	2024-08-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062687 application number: ANDA062687

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
63937KV33D	ERYTHROMYCIN	114-07-8	ERYTHROMYCIN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
318202	erythromycin 2 % Topical Solution	PSN	05cf40f6-1cef-42ea-8213-062880ce5aa2	3
318202	erythromycin 20 MG/ML Topical Solution	SCD	05cf40f6-1cef-42ea-8213-062880ce5aa2	3
318202	erythromycin 2 % Topical Solution	SY	05cf40f6-1cef-42ea-8213-062880ce5aa2	3
318202	erythromycin 2 % Topical Solution	PSN	cc75cae5-e320-cfa9-e053-2a95a90ab466	2
318202	erythromycin 20 MG/ML Topical Solution	SCD	cc75cae5-e320-cfa9-e053-2a95a90ab466	2
318202	erythromycin 2 % Topical Solution	SY	cc75cae5-e320-cfa9-e053-2a95a90ab466	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
42571-384-25	42571038425	1 BOTTLE in 1 CARTON (42571-384-25) > 60 mL in 1 BOTTLE	1 bottle	2021-06-04	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Erythromycin Topical Solution, USP 2%	MICRO LABS LIMITED \| Saptalis Pharmaceuticals, LLC.	2024-12-27	HUMAN PRESCRIPTION DRUG LABEL	3
Erythromycin Topical Solution, USP 2%	NuCare Pharmaceuticals,Inc.	2023-07-14	HUMAN PRESCRIPTION DRUG LABEL	2