Home NDC 69067-102-04 Dexchlorpheniramine Maleate
Product NDC 69067-102
Requested package NDC 69067-102-04
11-digit product format 690670102
Labeler code 69067
Product ID 69067-102_699f50be-2afc-4ca8-809e-cb283be343d1
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Dexchlorpheniramine Maleate
Dosage form SOLUTION
Route ORAL
Labeler Foxland Pharmaceuticals, Inc.
Application ANDA202520
Marketing category ANDA
Marketing start 2018-12-19
Marketing end 0000-00-00
Substance DEXCHLORPHENIRAMINE MALEATE
Active strength 2 mg/5mL
NDC exclude flag No
Listing certified through 2021-12-31
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 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
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 A202520-001 POLMON DEXCHLORPHENIRAMINE MALEATE 2MG/5ML SYRUP / ORAL RS 2018-07-16
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 · 44 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-10-15 13:18:30 2026-09 A202520-001 POLMON 2MG/5ML SYRUP / ORAL RS 2018-07-16 c2088c7a36db…2026-09-14 22:38:34 2026-08 A202520-001 POLMON 2MG/5ML SYRUP / ORAL RS 2018-07-16 84e616aacf4f…2026-08-18 06:07:40 2026-07 A202520-001 POLMON 2MG/5ML SYRUP / ORAL RS 2018-07-16 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A202520-001 POLMON 2MG/5ML SYRUP / ORAL RS 2018-07-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202520-001 POLMON 2MG/5ML SYRUP / ORAL RS 2018-07-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A202520-001 POLMON 2MG/5ML SYRUP / ORAL RS 2018-07-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202520-001 POLMON 2MG/5ML SYRUP / ORAL RS 2018-07-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202520-001 POLMON 2MG/5ML SYRUP / ORAL RS 2018-07-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A202520-001 POLMON 2MG/5ML SYRUP / ORAL RS 2018-07-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A202520-001 POLMON 2MG/5ML SYRUP / ORAL RS 2018-07-16 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A202520-001 POLMON 2MG/5ML SYRUP / ORAL RS 2018-07-16 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A202520-001 POLMON 2MG/5ML SYRUP / ORAL RS 2018-07-16 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A202520-001 POLMON 2MG/5ML SYRUP / ORAL RS 2018-07-16 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A202520-001 POLMON 2MG/5ML SYRUP / ORAL RS 2018-07-16 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A202520-001 POLMON 2MG/5ML SYRUP / ORAL RS 2018-07-16 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A202520-001 POLMON 2MG/5ML SYRUP / ORAL RS 2018-07-16 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A202520-001 POLMON 2MG/5ML SYRUP / ORAL RS 2018-07-16 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A202520-001 POLMON 2MG/5ML SYRUP / ORAL AA 2018-07-16 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A202520-001 POLMON 2MG/5ML SYRUP / ORAL AA 2018-07-16 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A202520-001 POLMON 2MG/5ML SYRUP / ORAL AA 2018-07-16 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A202520-001 POLMON 2MG/5ML SYRUP / ORAL AA 2018-07-16 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A202520-001 POLMON 2MG/5ML SYRUP / ORAL AA 2018-07-16 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A202520-001 POLMON 2MG/5ML SYRUP / ORAL AA 2018-07-16 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A202520-001 POLMON 2MG/5ML SYRUP / ORAL AA 2018-07-16 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A202520-001 POLMON 2MG/5ML SYRUP / ORAL AA 2018-07-16 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A202520-001 POLMON 2MG/5ML SYRUP / ORAL AA 2018-07-16 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A202520-001 POLMON 2MG/5ML SYRUP / ORAL AA 2018-07-16 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A202520-001 POLMON 2MG/5ML SYRUP / ORAL AA 2018-07-16 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A202520-001 POLMON 2MG/5ML SYRUP / ORAL AA 2018-07-16 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A202520-001 POLMON 2MG/5ML SYRUP / ORAL AA 2018-07-16 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A202520-001 POLMON 2MG/5ML SYRUP / ORAL AA 2018-07-16 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A202520-001 POLMON 2MG/5ML SYRUP / ORAL AA 2018-07-16 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A202520-001 POLMON 2MG/5ML SYRUP / ORAL AA 2018-07-16 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A202520-001 POLMON 2MG/5ML SYRUP / ORAL AA 2018-07-16 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A202520-001 POLMON 2MG/5ML SYRUP / ORAL AA 2018-07-16 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A202520-001 POLMON 2MG/5ML SYRUP / ORAL AA 2018-07-16 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A202520-001 POLMON 2MG/5ML SYRUP / ORAL AA 2018-07-16 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A202520-001 POLMON 2MG/5ML SYRUP / ORAL AA 2018-07-16 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A202520-001 POLMON 2MG/5ML SYRUP / ORAL AA 2018-07-16 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A202520-001 POLMON 2MG/5ML SYRUP / ORAL AA 2018-07-16 3a93d1ddd44b…
Observed Orange Book normalized TE history# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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 RYCLORA DEXCHLORPHENIRAMINE MALEATE CARWIN PHARMACEUTICAL ASSOCIATES, LLC aa4f80c9-e600-4bc0-8528-02a8162a36f0 2024-01-08 Warnings, Adverse reactions Exact identifier application applno (ANDA): 202520 application number: ANDA202520
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 69067-102-04 69067010204 118 mL in 1 BOTTLE, PLASTIC (69067-102-04) 118 ml 2018-12-19 0000-00-00 No No Current