Home NDC 0485-0098 ED CHLORPED JR
Product NDC 0485-0098
11-digit product format 004850098
Labeler code 0485
Product ID 0485-0098_423e5c5d-39b6-c528-e063-6394a90aab81
Type HUMAN OTC DRUG
Nonproprietary name CHLORPHENIRAMINE MALEATE
Dosage form LIQUID
Route ORAL
Labeler EDWARDS PHARMACEUTICALS, INC.
Marketing category UNAPPROVED DRUG OTHER
Marketing start 2011-03-04
Substance CHLORPHENIRAMINE MALEATE
Active strength 2 mg/5mL
Pharmacologic classes Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes 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 · 24 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 package package 0485-0098-04 D Discontinued by firm 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 0485-0098-16 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 0485-0098-04 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 0485-0098-04 D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 0485-0098-04 D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 0485-0098-04 D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 0485-0098-04 D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 0485-0098-04 D Discontinued by firm 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 0485-0098-04 D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 0485-0098-04 D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 0485-0098-04 D Discontinued by firm 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 0485-0098-16 I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 0485-0098-04 D Discontinued by firm 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 0485-0098-16 I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 0485-0098-04 D Discontinued by firm 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 0485-0098-16 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 0485-0098-16 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 0485-0098-16 I Inactivated by FDA 1332a3947898…d4bfe170f9cd…
Additional Listing Data#
Finished product Yes
Brand name base ED CHLORPED JR
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CHLORPHENIRAMINE MALEATE 2 mg/5mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination V1Q0O9OJ9Z Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1363306 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
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 0485-0098-04 ED CHLORPED JR 118 mL in 1 BOTTLE, PLASTIC LIQUID 118 9 0485-0098-16 ED CHLORPED JR 473 mL in 1 BOTTLE, PLASTIC LIQUID 473 9
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded CHLORPHENIRAMINE MALEATE ACTIVE INGREDIENT V1Q0O9OJ9Z ED CHLORPED JR (CHLORPHENIRAMINE MALEATE) LIQUID [EDWARDS PHARMACEUTICALS, INC.] 1 CHLORPHENIRAMINE ACTIVE MOIETY 3U6IO1965U ED CHLORPED JR (CHLORPHENIRAMINE MALEATE) LIQUID [EDWARDS PHARMACEUTICALS, INC.] 1 CITRIC ACID MONOHYDRATE INACTIVE INGREDIENT 2968PHW8QP ED CHLORPED JR (CHLORPHENIRAMINE MALEATE) LIQUID [EDWARDS PHARMACEUTICALS, INC.] 1 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA ED CHLORPED JR (CHLORPHENIRAMINE MALEATE) LIQUID [EDWARDS PHARMACEUTICALS, INC.] 1 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T ED CHLORPED JR (CHLORPHENIRAMINE MALEATE) LIQUID [EDWARDS PHARMACEUTICALS, INC.] 1 POTASSIUM CITRATE INACTIVE INGREDIENT EE90ONI6FF ED CHLORPED JR (CHLORPHENIRAMINE MALEATE) LIQUID [EDWARDS PHARMACEUTICALS, INC.] 1 POTASSIUM SORBATE INACTIVE INGREDIENT 1VPU26JZZ4 ED CHLORPED JR (CHLORPHENIRAMINE MALEATE) LIQUID [EDWARDS PHARMACEUTICALS, INC.] 1 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 ED CHLORPED JR (CHLORPHENIRAMINE MALEATE) LIQUID [EDWARDS PHARMACEUTICALS, INC.] 1 PROPYLPARABEN INACTIVE INGREDIENT Z8IX2SC1OH ED CHLORPED JR (CHLORPHENIRAMINE MALEATE) LIQUID [EDWARDS PHARMACEUTICALS, INC.] 1 SORBITOL INACTIVE INGREDIENT 506T60A25R ED CHLORPED JR (CHLORPHENIRAMINE MALEATE) LIQUID [EDWARDS PHARMACEUTICALS, INC.] 1 SUCRALOSE INACTIVE INGREDIENT 96K6UQ3ZD4 ED CHLORPED JR (CHLORPHENIRAMINE MALEATE) LIQUID [EDWARDS PHARMACEUTICALS, INC.] 1 WATER INACTIVE INGREDIENT 059QF0KO0R ED CHLORPED JR (CHLORPHENIRAMINE MALEATE) LIQUID [EDWARDS PHARMACEUTICALS, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0485-0098 ED CHLORPED JR (CHLORPHENIRAMINE MALEATE) LIQUID [EDWARDS PHARMACEUTICALS, INC.] 8 Current NDC, Legacy NDC, 2 package rows 20241109_4a5e5968-1930-465a-9b8c-45ed936a0e11.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0485-0098-04 00485009804 118 mL in 1 BOTTLE, PLASTIC 118 ml Historical 0485-0098-16 00485009816 473 mL in 1 BOTTLE, PLASTIC (0485-0098-16) 473 ml 2011-03-04 0000-00-00 No No Current