FDA.reportPublic FDA data

ED CHLORPED JR

Product NDC
0485-0098
Requested package NDC
0485-0098-16
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 · 6 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…

Additional Listing Data#

Finished product
Yes
Brand name base
ED CHLORPED JR
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CHLORPHENIRAMINE MALEATE2 mg/5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
V1Q0O9OJ9ZInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1363306Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
4a5e5968-1930-465a-9b8c-45ed936a0e11Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
d17a97fa-387f-690e-d2be-0083ab044a03Product name320170725
0fdb98e2-b951-a1ce-5715-2b187ba500efProduct name420170718
c6fba691-a132-4ede-95c6-f8c6bd696636Product name120150902
c0200ab5-4954-454e-9676-30b741b245bdProduct name120150730

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
0485-0098-042025-10-31ED CHLORPED JR.
0485-0098-042025-10-31ED CHLORPED JR.
0485-0098-162025-10-31ED CHLORPED JR.
0485-0098-162025-10-31ED CHLORPED JR.
0485-0098-042025-07-29ED CHLORPED JR.
0485-0098-042025-07-29ED CHLORPED JR.
0485-0098-162025-07-29ED CHLORPED JR.
0485-0098-162025-07-29ED CHLORPED JR.
0485-0098-042024-11-07ED CHLORPED JR.
0485-0098-042024-11-07ED CHLORPED JR.
0485-0098-162024-11-07ED CHLORPED JR.
0485-0098-162024-11-07ED CHLORPED JR.
0485-0098-042024-01-30ED CHLORPED JR.
0485-0098-042024-01-30ED CHLORPED JR.
0485-0098-162024-01-30ED CHLORPED JR.
0485-0098-162024-01-30ED CHLORPED JR.
0485-0098-042020-04-03ED CHLORPED JR.
0485-0098-042020-04-03ED CHLORPED JR.
0485-0098-162020-04-03ED CHLORPED JR.
0485-0098-162020-04-03ED CHLORPED JR.
0485-0098-042020-01-31ED CHLORPED JR.
0485-0098-042020-01-31ED CHLORPED JR.
0485-0098-162020-01-31ED CHLORPED JR.
0485-0098-162020-01-31ED CHLORPED JR.

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0485-0098-04ED CHLORPED JR118 mL in 1 BOTTLE, PLASTICLIQUID1189
0485-0098-16ED CHLORPED JR473 mL in 1 BOTTLE, PLASTICLIQUID4739

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0485-0098-04ML - Milliliter0485-009807fc0916-6f87-4963-872a-76c2c8e1d18412013-04-01
0485-0098-16ML - Milliliter0485-00988e07d008-3e2b-4576-b237-5f3d784a43a612013-04-01

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CHLORPHENIRAMINE MALEATEACTIVE INGREDIENTV1Q0O9OJ9ZED CHLORPED JR (CHLORPHENIRAMINE MALEATE) LIQUID [EDWARDS PHARMACEUTICALS, INC.]1
CHLORPHENIRAMINEACTIVE MOIETY3U6IO1965UED CHLORPED JR (CHLORPHENIRAMINE MALEATE) LIQUID [EDWARDS PHARMACEUTICALS, INC.]1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPED CHLORPED JR (CHLORPHENIRAMINE MALEATE) LIQUID [EDWARDS PHARMACEUTICALS, INC.]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAED CHLORPED JR (CHLORPHENIRAMINE MALEATE) LIQUID [EDWARDS PHARMACEUTICALS, INC.]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TED CHLORPED JR (CHLORPHENIRAMINE MALEATE) LIQUID [EDWARDS PHARMACEUTICALS, INC.]1
POTASSIUM CITRATEINACTIVE INGREDIENTEE90ONI6FFED CHLORPED JR (CHLORPHENIRAMINE MALEATE) LIQUID [EDWARDS PHARMACEUTICALS, INC.]1
POTASSIUM SORBATEINACTIVE INGREDIENT1VPU26JZZ4ED CHLORPED JR (CHLORPHENIRAMINE MALEATE) LIQUID [EDWARDS PHARMACEUTICALS, INC.]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3ED CHLORPED JR (CHLORPHENIRAMINE MALEATE) LIQUID [EDWARDS PHARMACEUTICALS, INC.]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHED CHLORPED JR (CHLORPHENIRAMINE MALEATE) LIQUID [EDWARDS PHARMACEUTICALS, INC.]1
SORBITOLINACTIVE INGREDIENT506T60A25RED CHLORPED JR (CHLORPHENIRAMINE MALEATE) LIQUID [EDWARDS PHARMACEUTICALS, INC.]1
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD4ED CHLORPED JR (CHLORPHENIRAMINE MALEATE) LIQUID [EDWARDS PHARMACEUTICALS, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RED CHLORPED JR (CHLORPHENIRAMINE MALEATE) LIQUID [EDWARDS PHARMACEUTICALS, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0485-0098ED CHLORPED JR (CHLORPHENIRAMINE MALEATE) LIQUID [EDWARDS PHARMACEUTICALS, INC.]8Current NDC, Legacy NDC, 2 package rows20241109_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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ED CHLORPED JRCHLORPHENIRAMINE MALEATEEDWARDS PHARMACEUTICALS, INC.4a5e5968-1930-465a-9b8c-45ed936a0e112025-10-28WarningsExact identifier
ndc (package): 0485-0098-16
ndc (product): 0485-0098
ndc11 (package): 00485009816

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1363306chlorpheniramine maleate 2 MG in 5 mL Oral SolutionPSN4a5e5968-1930-465a-9b8c-45ed936a0e119
1363306chlorpheniramine maleate 0.4 MG/ML Oral SolutionSCD4a5e5968-1930-465a-9b8c-45ed936a0e119
1363306chlorpheniramine maleate 2 MG per 5 ML Oral SolutionSY4a5e5968-1930-465a-9b8c-45ed936a0e119

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0485-0098-1600485009816473 mL in 1 BOTTLE, PLASTIC (0485-0098-16) 473 ml2011-03-040000-00-00NoNoCurrent