Erythromycin and Benzoyl Peroxide

Product NDC
68682-900
11-digit product format
686820900
Labeler code
68682
Product ID
68682-900_eba108cb-67ec-4f94-8fad-0afb3a52899b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Erythromycin and Benzoyl Peroxide
Dosage form
KIT
Labeler
Oceanside Pharmaceuticals
Application
NDA050557
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
1984-10-26
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N050557-001BENZAMYCINBENZOYL PEROXIDE; ERYTHROMYCIN5%;3%GEL / TOPICALABRLD, RS1984-10-26

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
N050557-001AB

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N050557-001BENZAMYCIN5%;3%GEL / TOPICALABRLD, RS1984-10-26011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N050557-001BENZAMYCIN5%;3%GEL / TOPICALABRLD, RS1984-10-2631067a03dcf5…
2025-08-23 18:47 UTC2025-08N050557-001BENZAMYCIN5%;3%GEL / TOPICALABRLD, RS1984-10-266a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N050557-001BENZAMYCIN5%;3%GEL / TOPICALABRLD, RS1984-10-26fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N050557-001BENZAMYCIN5%;3%GEL / TOPICALABRLD, RS1984-10-26b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N050557-001BENZAMYCIN5%;3%GEL / TOPICALABRLD, RS1984-10-2603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N050557-001BENZAMYCIN5%;3%GEL / TOPICALABRLD, RS1984-10-262680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N050557-001BENZAMYCIN5%;3%GEL / TOPICALABRLD, RS1984-10-265bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N050557-001BENZAMYCIN5%;3%GEL / TOPICALABRLD, RS1984-10-26d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N050557-001BENZAMYCIN5%;3%GEL / TOPICALABRLD, RS1984-10-26d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N050557-001BENZAMYCIN5%;3%GEL / TOPICALABRLD, RS1984-10-2679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N050557-001BENZAMYCIN5%;3%GEL / TOPICALABRLD, RS1984-10-26301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N050557-001BENZAMYCIN5%;3%GEL / TOPICALABRLD, RS1984-10-261e350fbaab3a…
2024-05-31 18:47 UTC2024-05N050557-001BENZAMYCIN5%;3%GEL / TOPICALABRLD, RS1984-10-268072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N050557-001BENZAMYCIN5%;3%GEL / TOPICALABRLD, RS1984-10-265c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N050557-001BENZAMYCIN5%;3%GEL / TOPICALABRLD, RS1984-10-265d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N050557-001BENZAMYCIN5%;3%GEL / TOPICALABRLD, RS1984-10-264b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N050557-001BENZAMYCIN5%;3%GEL / TOPICALABRLD, RS1984-10-2674a2ff9319b5…
2022-03-09 01:35 UTC2022-03N050557-001BENZAMYCIN5%;3%GEL / TOPICALABRLD, RS1984-10-26bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N050557-001BENZAMYCIN5%;3%GEL / TOPICALABRLD, RS1984-10-26782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N050557-001BENZAMYCIN5%;3%GEL / TOPICALABRLD, RS1984-10-2687673890dc5c…
2021-03-12 10:30 UTC2021-03N050557-001BENZAMYCIN5%;3%GEL / TOPICALABRLD, RS1984-10-265aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N050557-001BENZAMYCIN5%;3%GEL / TOPICALABRLD, RS1984-10-268869cabd3fbd…
2020-11-12 02:37 UTC2020-11N050557-001BENZAMYCIN5%;3%GEL / TOPICALABRLD, RS1984-10-26c0c555d07b60…
2019-12-14 00:12 UTC2019-12N050557-001BENZAMYCIN5%;3%GEL / TOPICALABRLD, RS1984-10-263f01610625f2…
2019-09-15 20:21 UTC2019-09N050557-001BENZAMYCIN5%;3%GEL / TOPICALABRLD, RS1984-10-26b00525d2431f…
2019-07-19 19:46 UTC2019-07N050557-001BENZAMYCIN5%;3%GEL / TOPICALABRLD, RS1984-10-26ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N050557-001BENZAMYCIN5%;3%GEL / TOPICALABRLD, RS1984-10-266a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N050557-001BENZAMYCIN5%;3%GEL / TOPICALABRLD, RS1984-10-261c564ffb4f44…
2023-12-20 04:57 UTC2023-12N050557-001BENZAMYCIN5%;3%GEL / TOPICALABRLD, RS1984-10-26ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N050557-001BENZAMYCIN5%;3%GEL / TOPICALABRLD, RS1984-10-26a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N050557-001BENZAMYCIN5%;3%GEL / TOPICALABRLD, RS1984-10-269b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N050557-001BENZAMYCIN5%;3%GEL / TOPICALABRLD, RS1984-10-26a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N050557-001BENZAMYCIN5%;3%GEL / TOPICALABRLD, RS1984-10-263f0d92c62455…
2023-05-13 08:27 UTC2023-05N050557-001BENZAMYCIN5%;3%GEL / TOPICALABRLD, RS1984-10-26053a50430f4f…
2023-01-26 05:58 UTC2023-01N050557-001BENZAMYCIN5%;3%GEL / TOPICALABRLD, RS1984-10-263bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N050557-001BENZAMYCIN5%;3%GEL / TOPICALABRLD, RS1984-10-263a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N050557-001BENZAMYCIN5%;3%GEL / TOPICALABRLD, RS1984-10-26f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N050557-001BENZAMYCIN5%;3%GEL / TOPICALABRLD, RS1984-10-26e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N050557-001BENZAMYCIN5%;3%GEL / TOPICALABRLD, RS1984-10-26cb3db0bc1861…

Observed Orange Book normalized TE history#

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

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02N050557-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N050557-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08N050557-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N050557-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N050557-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N050557-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N050557-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N050557-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N050557-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N050557-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N050557-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N050557-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N050557-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N050557-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N050557-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N050557-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N050557-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N050557-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N050557-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N050557-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N050557-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03N050557-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N050557-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11N050557-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12N050557-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09N050557-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07N050557-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N050557-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N050557-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12N050557-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N050557-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N050557-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N050557-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N050557-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05N050557-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01N050557-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N050557-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N050557-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N050557-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N050557-001AB1cb3db0bc1861…

Additional Listing Data#

Finished product
Yes
Brand name base
Erythromycin and Benzoyl Peroxide
Listing expiration
2026-12-31

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
244374Internal RxNorm lookup
308694Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
be5bce27-bbb7-4503-b609-d89a77ee1e05Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a46239a7-5963-4008-8cbb-6b9000f497ebProduct name120250721
d329c2e1-5ae8-4e64-aea0-77ecea3fa1abProduct name320250717
b382b4e1-6b48-45f6-bffc-e61b00b0ce19Product name320250317
3b331500-3b74-bd2b-fede-d46839f2f4d5Product name620240313
fdae2630-eae0-4769-abfd-8f33d5b771b4Product name320240202
d9d61457-6a5a-41fc-b418-e5479a2904b7Product name220230303
32012d5c-25ac-49c7-9d4c-1313177fff7cProduct name120230112
13e7e7e3-e885-4c79-af6d-dad1aedbb06eProduct name120220128
4a7d44fe-774d-404b-aad0-8a90fe78375aProduct name420211025
3f45980c-c196-47e5-0e5e-48b7c57327c5Product name520200428
d12e2d7c-bd6b-45d4-94f9-6df8e1b8b27bProduct name320200203
8c898317-b543-1e4e-254f-84cec2f3f57eProduct name220191002
ee5c6de5-d9cd-454f-b250-7b19e5cf2992Product name420190619
64ae94c0-3212-d73a-92da-9e6dd85c6ebeProduct name220180118
edcfa1cf-915f-1a4c-d0aa-508cc66e70d9Product name220170816
ad75fcfd-a339-42a1-9c60-43ba2c654cfaProduct name120170810
57850177-5927-151f-e1fa-7e2ca47f81e5Product name120140508
8ee71591-1d8f-e24e-242b-bfef131e3168Product name120140508
bff5cf99-0f45-fa15-2a76-b160c3c4cc3cProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68682-900-23Erythromycin and Benzoyl Peroxide1 in 1 CARTONKIT19
68682-923-23Erythromycin and Benzoyl Peroxide20 g in 1 JARGEL20 g50 mg in 1g9
68682-924-08Erythromycin and Benzoyl Peroxide0.8 g in 1 VIAL, PLASTICGEL0.8 g30 mg in 1g9

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68682-900-23GM - Gram68682-9003d94ae53-f1f5-45e2-9cb2-02c0f57976eb12015-04-03

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68682-900ERYTHROMYCIN AND BENZOYL PEROXIDE KIT [OCEANSIDE PHARMACEUTICALS]9Current NDC, Legacy NDC, 3 package rows20191010_be5bce27-bbb7-4503-b609-d89a77ee1e05.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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BenzamycinERYTHROMYCIN AND BENZOYL PEROXIDEBausch Health US, LLCc8c05e98-ec28-4636-8e5c-9a2557483e3c2020-11-30Warnings, Adverse reactionsExact identifier
application applno (NDA): 050557
application number: NDA050557
Erythromycin and Benzoyl PeroxideERYTHROMYCIN AND BENZOYL PEROXIDEOceanside Pharmaceuticalsbe5bce27-bbb7-4503-b609-d89a77ee1e052019-06-03Warnings, Adverse reactionsExact identifier
application applno (NDA): 050557
application number: NDA050557
ndc (product): 68682-900

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308694benzoyl peroxide 5 % Topical GelPSNbe5bce27-bbb7-4503-b609-d89a77ee1e059
244374erythromycin 3 % / benzoyl peroxide 5 % Topical GelPSNbe5bce27-bbb7-4503-b609-d89a77ee1e059
244374benzoyl peroxide 0.05 MG/MG / erythromycin 0.03 MG/MG Topical GelSCDbe5bce27-bbb7-4503-b609-d89a77ee1e059
308694benzoyl peroxide 0.05 MG/MG Topical GelSCDbe5bce27-bbb7-4503-b609-d89a77ee1e059
244374benzoyl peroxide 5 % / erythromycin 3 % Topical GelSYbe5bce27-bbb7-4503-b609-d89a77ee1e059
308694benzoyl peroxide 5 % Topical GelSYbe5bce27-bbb7-4503-b609-d89a77ee1e059
244374benzoyl peroxide 50 MG / erythromycin 30 MG per GM Topical GelSYbe5bce27-bbb7-4503-b609-d89a77ee1e059

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68682-900-23686820900231 KIT in 1 CARTON (68682-900-23) * .8 g in 1 VIAL, PLASTIC (68682-924-08) * 20 g in 1 JAR (68682-923-23) 1 kit1984-10-260000-00-00NoNoCurrent
68682-923-236868209232320 g in 1 JAR20 gHistorical
68682-924-08686820924080.8 g in 1 VIAL, PLASTIC0.8 gHistorical