FDA.reportPublic FDA data

Tricode

Product NDC
60575-313
11-digit product format
605750313
Labeler code
60575
Product ID
60575-313_cfbbbfc0-ceb1-42b7-927b-6dcc58e30f1f
Type
HUMAN OTC DRUG
Nonproprietary name
Chlorpheniramine Maleate, Codeine Phosphate, Pseudoephedrine Hydrochloride
Dosage form
LIQUID
Route
ORAL
Labeler
Respa Pharmaceuticals, Inc.
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2011-06-20
Marketing end
0000-00-00
Substance
CHLORPHENIRAMINE MALEATE; CODEINE PHOSPHATE; PSEUDOEPHEDRINE HYDROCHLORIDE
Active strength
2 mg/5mL; mg/5mL; mg/5mL
DEA schedule
CV
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
41b814f3-0166-1c53-c9ef-a0794c7daf9dProduct name320221110
a590be26-846c-8659-a5a1-fb25907965dcProduct name220221110
09d8330d-4fec-be98-3a66-f985140646b2Product name220210513
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
20c8cafe-5cfc-44f8-a9be-a664f437f780Product name220200225
d17a97fa-387f-690e-d2be-0083ab044a03Product name320170725
0fdb98e2-b951-a1ce-5715-2b187ba500efProduct name420170718
e974e22d-8688-7d92-1e87-40c1079e170cProduct name320151125
182f9ab4-4ab5-c449-200f-87ce2ce8e550Product name220151105
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
c6fba691-a132-4ede-95c6-f8c6bd696636Product name120150902
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
c0200ab5-4954-454e-9676-30b741b245bdProduct name120150730
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
2a21311a-89e2-0e83-2ebd-117f9798b2b2Product name120140508
30c51294-7ae9-8007-7de6-58222684a0beProduct name120140508
47fd879b-91c5-e1e5-130f-29d082a871ecProduct name120140508
4f26f669-fc6c-40ef-9e26-1c7b2390ee66Product name120140508
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
70a83adc-6047-bbea-5a08-dfd304aa47d2Product name120140508
858ce051-9941-aafc-8c7c-44a8e0227463Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
b893258d-0942-3d8a-3411-056ea0788ff5Product name120140508
c35d1ac8-8885-2ee1-6c52-5a715b242c00Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
60575-313-162019-11-13C16284748780-197449f38-be70-f6ea-e053-dbdaa90aa703Tricode AR

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60575-313-16TricodeAR473 mL in 1 BOTTLELIQUID4732

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60575-313-16ML - Milliliter60575-313db0738bf-35fa-4e53-afb5-111752f35b7712012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Chlorpheniramine MaleateACTIVE INGREDIENTV1Q0O9OJ9ZTRICODE AR (CHLORPHENIRAMINE MALEATE, CODEINE PHOSPHATE, PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [RESPA PHARMACEUTICALS, INC.]2
Codeine PhosphateACTIVE INGREDIENTGSL05Y1MN6TRICODE AR (CHLORPHENIRAMINE MALEATE, CODEINE PHOSPHATE, PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [RESPA PHARMACEUTICALS, INC.]2
Pseudoephedrine HydrochlorideACTIVE INGREDIENT6V9V2RYJ8NTRICODE AR (CHLORPHENIRAMINE MALEATE, CODEINE PHOSPHATE, PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [RESPA PHARMACEUTICALS, INC.]2
ChlorpheniramineACTIVE MOIETY3U6IO1965UTRICODE AR (CHLORPHENIRAMINE MALEATE, CODEINE PHOSPHATE, PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [RESPA PHARMACEUTICALS, INC.]2
CodeineACTIVE MOIETYQ830PW7520TRICODE AR (CHLORPHENIRAMINE MALEATE, CODEINE PHOSPHATE, PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [RESPA PHARMACEUTICALS, INC.]2
PseudoephedrineACTIVE MOIETY7CUC9DDI9FTRICODE AR (CHLORPHENIRAMINE MALEATE, CODEINE PHOSPHATE, PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [RESPA PHARMACEUTICALS, INC.]2
Citric AcidINACTIVE INGREDIENT2968PHW8QPTRICODE AR (CHLORPHENIRAMINE MALEATE, CODEINE PHOSPHATE, PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [RESPA PHARMACEUTICALS, INC.]2
GlycerinINACTIVE INGREDIENTPDC6A3C0OXTRICODE AR (CHLORPHENIRAMINE MALEATE, CODEINE PHOSPHATE, PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [RESPA PHARMACEUTICALS, INC.]2
Propylene GlycolINACTIVE INGREDIENT6DC9Q167V3TRICODE AR (CHLORPHENIRAMINE MALEATE, CODEINE PHOSPHATE, PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [RESPA PHARMACEUTICALS, INC.]2
Saccharin SodiumINACTIVE INGREDIENTSB8ZUX40TYTRICODE AR (CHLORPHENIRAMINE MALEATE, CODEINE PHOSPHATE, PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [RESPA PHARMACEUTICALS, INC.]2
Sodium CitrateINACTIVE INGREDIENT1Q73Q2JULRTRICODE AR (CHLORPHENIRAMINE MALEATE, CODEINE PHOSPHATE, PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [RESPA PHARMACEUTICALS, INC.]2
SorbitolINACTIVE INGREDIENT506T60A25RTRICODE AR (CHLORPHENIRAMINE MALEATE, CODEINE PHOSPHATE, PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [RESPA PHARMACEUTICALS, INC.]2
WaterINACTIVE INGREDIENT059QF0KO0RTRICODE AR (CHLORPHENIRAMINE MALEATE, CODEINE PHOSPHATE, PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [RESPA PHARMACEUTICALS, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60575-313TRICODE AR (CHLORPHENIRAMINE MALEATE, CODEINE PHOSPHATE, PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [RESPA PHARMACEUTICALS, INC.]2Legacy NDC, 1 package rows20111014_2548c67a-dfff-4cfb-8f51-a1006cf54a2f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1114003codeine phosphate 8 MG / chlorpheniramine maleate 2 MG / pseudoephedrine HCl 30 MG in 5 mL Oral SolutionPSN2548c67a-dfff-4cfb-8f51-a1006cf54a2f2
1114003chlorpheniramine maleate 0.4 MG/ML / codeine phosphate 1.6 MG/ML / pseudoephedrine hydrochloride 6 MG/ML Oral SolutionSCD2548c67a-dfff-4cfb-8f51-a1006cf54a2f2
1114003chlorpheniramine maleate 2 MG / codeine phosphate 8 MG / pseudoephedrine hydrochloride 30 MG per 5 ML Oral SolutionSY2548c67a-dfff-4cfb-8f51-a1006cf54a2f2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
60575-313-1660575031316473 mL in 1 BOTTLE473 mlHistorical