FDA.reportPublic FDA data

SudoGest

Product NDC
0904-5351
Requested package NDC
0904-5351-24
11-digit product format
009045351
Labeler code
0904
Product ID
0904-5351_1b9122c9-f8eb-494a-b64b-cc16ca154e29
Type
HUMAN OTC DRUG
Nonproprietary name
Chlorpheniramine maleate, pseudoephedrine HCl
Dosage form
TABLET
Route
ORAL
Labeler
Major Pharmaceuticals
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
1992-12-16
Substance
CHLORPHENIRAMINE MALEATE; PSEUDOEPHEDRINE HYDROCHLORIDE
Active strength
4; 60 mg/1; mg/1
Pharmacologic classes
Adrenergic alpha-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], alpha-Adrenergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
SudoGest
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CHLORPHENIRAMINE MALEATE4 mg/1
PSEUDOEPHEDRINE HYDROCHLORIDE60 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
V1Q0O9OJ9ZInternal UNII lookup
6V9V2RYJ8NInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
998254Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
7cd8f7f3-c262-4f7c-bcaf-068be2c952f9Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
d17a97fa-387f-690e-d2be-0083ab044a03Product name320170725
0fdb98e2-b951-a1ce-5715-2b187ba500efProduct name420170718
e974e22d-8688-7d92-1e87-40c1079e170cProduct name320151125
c6fba691-a132-4ede-95c6-f8c6bd696636Product name120150902
c0200ab5-4954-454e-9676-30b741b245bdProduct name120150730
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
30c51294-7ae9-8007-7de6-58222684a0beProduct name120140508
4f26f669-fc6c-40ef-9e26-1c7b2390ee66Product name120140508
70a83adc-6047-bbea-5a08-dfd304aa47d2Product name120140508
858ce051-9941-aafc-8c7c-44a8e0227463Product name120140508
b893258d-0942-3d8a-3411-056ea0788ff5Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0904-5351-24SudoGest24 in 1 BLISTER PACKTABLET2422
0904-5351-24SudoGest1 in 1 CARTONTABLET122
0904-5351-96SudoGest2 in 1 CARTONTABLET222
0904-5351-96SudoGest24 in 1 BLISTER PACKTABLET2422

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-5351-24EA - Each0904-53510f9a6680-4520-4451-8edd-397fa5e3476b12013-02-13
0904-5351-96EA - Each0904-535142cabb83-be5b-4ab6-8e48-2ec71619f10312013-07-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CHLORPHENIRAMINE MALEATEACTIVE INGREDIENTV1Q0O9OJ9ZSUDOGEST (CHLORPHENIRAMINE MALEATE PSEUDOEPHEDRINE HCL) TABLET [MAJOR PHARMACEUTICALS]8
PSEUDOEPHEDRINE HYDROCHLORIDEACTIVE INGREDIENT6V9V2RYJ8NSUDOGEST (CHLORPHENIRAMINE MALEATE PSEUDOEPHEDRINE HCL) TABLET [MAJOR PHARMACEUTICALS]8
CHLORPHENIRAMINEACTIVE MOIETY3U6IO1965USUDOGEST (CHLORPHENIRAMINE MALEATE PSEUDOEPHEDRINE HCL) TABLET [MAJOR PHARMACEUTICALS]8
PSEUDOEPHEDRINEACTIVE MOIETY7CUC9DDI9FSUDOGEST (CHLORPHENIRAMINE MALEATE PSEUDOEPHEDRINE HCL) TABLET [MAJOR PHARMACEUTICALS]8
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKSUDOGEST (CHLORPHENIRAMINE MALEATE PSEUDOEPHEDRINE HCL) TABLET [MAJOR PHARMACEUTICALS]8
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USUDOGEST (CHLORPHENIRAMINE MALEATE PSEUDOEPHEDRINE HCL) TABLET [MAJOR PHARMACEUTICALS]8
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48SUDOGEST (CHLORPHENIRAMINE MALEATE PSEUDOEPHEDRINE HCL) TABLET [MAJOR PHARMACEUTICALS]8
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SUDOGEST (CHLORPHENIRAMINE MALEATE PSEUDOEPHEDRINE HCL) TABLET [MAJOR PHARMACEUTICALS]8
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4SUDOGEST (CHLORPHENIRAMINE MALEATE PSEUDOEPHEDRINE HCL) TABLET [MAJOR PHARMACEUTICALS]8
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APSUDOGEST (CHLORPHENIRAMINE MALEATE PSEUDOEPHEDRINE HCL) TABLET [MAJOR PHARMACEUTICALS]8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-5351SUDOGEST (CHLORPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HCL) TABLET [MAJOR PHARMACEUTICALS]20Current NDC, Legacy NDC, 4 package rows20250217_7cd8f7f3-c262-4f7c-bcaf-068be2c952f9.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 195 · 3,893 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Severe Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLCardinal Health 110, LLC. DBA Leader610accad-2f8b-4605-9357-a58e6e18d4172026-08-15WarningsExact identifier
application number: M012
CVS Childrens COLD PLUS COUGH PLUS SORE THROATACETAMINOPHEN AND DEXTROMETHORPHAN HYDROBROMIDECVS PHARMACY27820bce-6638-4f17-ac66-62b02b76bec32026-08-14WarningsExact identifier
application number: M012
CVS PHARMACY Childrens Cold and AllergyBROMPHENIRAMINE MALEATECVS PHARMACY, INC.004e104b-d6ff-48d5-8685-cd1bff45399a2026-08-14WarningsExact identifier
application number: M012
CHILDRENS DIMETAPP COLD AND COUGHBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLCVS PHARMACY7babf4f6-ca0a-44a7-b1ea-d60e20d36f152026-08-14WarningsExact identifier
application number: M012
CVS Mucus Relief DM and Overnight Cold and FluDEXTROMETHORPHAN HBR, GUAIFENESIN, ACETAMINOPHEN AND TRIPROLIDINE HCLCVS75520b77-d40b-4f43-b92a-7a3eba5b493f2026-08-14WarningsExact identifier
application number: M012
CVS Severe Multi-Symptom Cough Cold FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDECVS PHARMACYbb24c298-1d00-4378-8de3-b4056220fa752026-08-14WarningsExact identifier
application number: M012
SEVERE COLD PLUS FLU DAYTIME NIGHTTIMEACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, AND DOXYLAMINE SUCCINATECVS Pharmacy,Inc.6cb1d08b-e544-4084-b9ed-1e0d99a709c82026-08-14Warnings, Adverse reactionsExact identifier
application number: M012
Theraflu Relief Max Strength DaytimeACETAMINOPHEN, DEXTROMETHORPHAN HBRCVS PHARMACY932a3d40-9b52-4e91-bc61-6fd506f2d9e62026-08-14WarningsExact identifier
application number: M012
Multi Symptom Severe Cold and Nighttime Severe Cold and CoughACETAMINOPHEN, DEXTROMETHORPHAN HBR, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCLCVS Pharmacy,Inc.91063edd-1e7e-41e9-8412-b14ef37490182026-08-14WarningsExact identifier
application number: M012
CVS Childrens Cold and AllergyBROMPHENIRAMINE MALEATE, PHENYLEPHRINE HCLCVS PHARMACY, INC.f4020c08-29f6-4609-834e-191ce68851302026-08-14WarningsExact identifier
application number: M012
CVS Severe Cough, Flu Plus Sore Throat HoneyACETAMINOPHEN, DEXTROMETHORPHAN HBRCVS PHARMACY95203001-7ca6-4513-83a3-9ef17855bc0f2026-08-14WarningsExact identifier
application number: M012
Daytime Cold and Flu ReliefACETAMINOHPEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLCVS PHARMACY81d26e9c-b713-4fb3-b0a5-68526bad230e2026-08-14WarningsExact identifier
application number: M012
Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEWalgreen Companye9d0b6f9-e9f3-431c-9f34-4d63108282a12026-08-13WarningsExact identifier
application number: M012
daytime nighttime severe cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HCLAmazon.com Services LLC9bb6bbd5-508e-4781-ad1c-69ccf0a5f13e2026-08-13WarningsExact identifier
application number: M012
Daytime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLAmazon.com Services LLC1e3c81b0-05de-4c4a-8579-f301f14626b32026-08-13WarningsExact identifier
application number: M012
Tussin DM Daytime NighttimeDEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFENESINCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDd59f6c64-8311-48ba-90d1-8000b04bfcda2026-08-13WarningsExact identifier
application number: M012
TYLENOL COLD PLUS FLU MULTI-SYMPTOM GELS DAY PLUS NIGHTACETAMINOPHEN,DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEKenvue Brands LLC1c5578e6-7e67-c467-e063-6294a90a6e0b2026-08-12WarningsExact identifier
application number: M012
Nighttime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEAmazon.com Services LLCf95220c5-e55c-4271-a267-d004ad2447bf2026-08-12WarningsExact identifier
application number: M012
CVS PHARMACY Childrens Allergy ChewsDIPHENHYDRAMINE HCLCVS PHARMACY, INC.569b8efa-8458-49f7-a665-6b7016a105052026-08-12WarningsExact identifier
application number: M012
CVS PHARMACY DYE FREE Childrens Allergy ChewsDIPHENHYDRAMINE HCLCVS PHARMACY, INC.e6671e8b-653a-4f4e-b6f3-e31fcd14fbd72026-08-12WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
998254pseudoephedrine HCl 60 MG / chlorpheniramine maleate 4 MG Oral TabletPSN7cd8f7f3-c262-4f7c-bcaf-068be2c952f922
998254chlorpheniramine maleate 4 MG / pseudoephedrine hydrochloride 60 MG Oral TabletSCD7cd8f7f3-c262-4f7c-bcaf-068be2c952f922

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0904-5351-24009045351241 BLISTER PACK in 1 CARTON (0904-5351-24) / 24 TABLET in 1 BLISTER PACK1 blister pack1992-12-160000-00-00NoNoCurrent