Home NDC 57520-0711 Acne
Product NDC 57520-0711
11-digit product format 575200711
Labeler code 57520
Product ID 57520-0711_eda9f5bc-1a20-4591-b1c1-3b015952c8db
Type HUMAN OTC DRUG
Nonproprietary name Kali bromatum, Natrum bromatum, Niccolum sulphuricum, Sulphur, Hepar sulphurs calcareum,
Dosage form TABLET
Route ORAL
Labeler Apotheca Company
Marketing category UNAPPROVED HOMEOPATHIC
Marketing start 2011-06-29
Marketing end 0000-00-00
Substance POTASSIUM BROMIDE; SODIUM BROMIDE; NICKEL SULFATE HEXAHYDRATE; SULFUR; CALCIUM SULFIDE
Active strength 1 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1
NDC exclude flag E
Listing certified through 2018-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 44 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 57520-0711-3 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 57520-0711-3 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 57520-0711-3 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 57520-0711-3 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 57520-0711-3 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 57520-0711-3 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product I Inactivated by FDA 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 57520-0711-3 I Inactivated by FDA 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product I Inactivated by FDA ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 57520-0711-3 I Inactivated by FDA ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product I Inactivated by FDA 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 57520-0711-3 I Inactivated by FDA 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 57520-0711-3 I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 57520-0711-3 I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 57520-0711-3 I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 57520-0711-3 I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product I Inactivated by FDA 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 57520-0711-3 I Inactivated by FDA 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 57520-0711-3 I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2022-08-30 03:57 UTC · source 2022-08-29 excluded product product I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 57520-0711-3 I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 excluded product product I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 57520-0711-3 I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded product product I Inactivated by FDA bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 57520-0711-3 I Inactivated by FDA bd6a592717d7…303034d00443…2021-12-27 23:28 UTC · source 2021-12-27 excluded product product I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 57520-0711-3 I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…2020-12-18 03:04 UTC · source 2020-12-17 excluded product product I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 57520-0711-3 I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 57520-0711-3 I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2019-12-08 06:16 UTC · source 2019-12-05 excluded product product E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 57520-0711-3 E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 57520-0711-1 Acne 100 in 1 BOTTLE TABLET 100 1 57520-0711-2 Acne 1 in 1 CARTON TABLET 1 1 57520-0711-3 Acne 1 in 1 CARTON TABLET 1 1
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded CALCIUM SULFIDE ACTIVE INGREDIENT 1MBW07J51Q ACNE (KALI BROMATUM, NATRUM BROMATUM, NICCOLUM SULPHURICUM, SULPHUR, HEPAR SULPHURS CALCAREUM,) TABLET [APOTHECA COMPANY] 1 NICKEL SULFATE HEXAHYDRATE ACTIVE INGREDIENT JC9WZ4FK68 ACNE (KALI BROMATUM, NATRUM BROMATUM, NICCOLUM SULPHURICUM, SULPHUR, HEPAR SULPHURS CALCAREUM,) TABLET [APOTHECA COMPANY] 1 POTASSIUM BROMIDE ACTIVE INGREDIENT OSD78555ZM ACNE (KALI BROMATUM, NATRUM BROMATUM, NICCOLUM SULPHURICUM, SULPHUR, HEPAR SULPHURS CALCAREUM,) TABLET [APOTHECA COMPANY] 1 SODIUM BROMIDE ACTIVE INGREDIENT LC1V549NOM ACNE (KALI BROMATUM, NATRUM BROMATUM, NICCOLUM SULPHURICUM, SULPHUR, HEPAR SULPHURS CALCAREUM,) TABLET [APOTHECA COMPANY] 1 SULFUR ACTIVE INGREDIENT 70FD1KFU70 ACNE (KALI BROMATUM, NATRUM BROMATUM, NICCOLUM SULPHURICUM, SULPHUR, HEPAR SULPHURS CALCAREUM,) TABLET [APOTHECA COMPANY] 1 CALCIUM CATION ACTIVE MOIETY 2M83C4R6ZB ACNE (KALI BROMATUM, NATRUM BROMATUM, NICCOLUM SULPHURICUM, SULPHUR, HEPAR SULPHURS CALCAREUM,) TABLET [APOTHECA COMPANY] 1 NICKEL ACTIVE MOIETY 7OV03QG267 ACNE (KALI BROMATUM, NATRUM BROMATUM, NICCOLUM SULPHURICUM, SULPHUR, HEPAR SULPHURS CALCAREUM,) TABLET [APOTHECA COMPANY] 1 POTASSIUM CATION ACTIVE MOIETY 295O53K152 ACNE (KALI BROMATUM, NATRUM BROMATUM, NICCOLUM SULPHURICUM, SULPHUR, HEPAR SULPHURS CALCAREUM,) TABLET [APOTHECA COMPANY] 1 SODIUM CATION ACTIVE MOIETY LYR4M0NH37 ACNE (KALI BROMATUM, NATRUM BROMATUM, NICCOLUM SULPHURICUM, SULPHUR, HEPAR SULPHURS CALCAREUM,) TABLET [APOTHECA COMPANY] 1 SULFUR ACTIVE MOIETY 70FD1KFU70 ACNE (KALI BROMATUM, NATRUM BROMATUM, NICCOLUM SULPHURICUM, SULPHUR, HEPAR SULPHURS CALCAREUM,) TABLET [APOTHECA COMPANY] 1 LACTOSE INACTIVE INGREDIENT J2B2A4N98G ACNE (KALI BROMATUM, NATRUM BROMATUM, NICCOLUM SULPHURICUM, SULPHUR, HEPAR SULPHURS CALCAREUM,) TABLET [APOTHECA COMPANY] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 ACNE (KALI BROMATUM, NATRUM BROMATUM, NICCOLUM SULPHURICUM, SULPHUR, HEPAR SULPHURS CALCAREUM,) TABLET [APOTHECA COMPANY] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 57520-0711 ACNE (KALI BROMATUM, NATRUM BROMATUM, NICCOLUM SULPHURICUM, SULPHUR, HEPAR SULPHURS CALCAREUM,) TABLET [APOTHECA COMPANY] 1 Legacy NDC, 3 package rows 20110630_f4ca87b4-e222-4c90-9423-c84b6a5668ad.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Status 57520-0711-1 57520071101 100 in 1 BOTTLE Historical 57520-0711-2 57520071102 1 in 1 CARTON Historical 57520-0711-3 57520071103 1 in 1 CARTON Historical