FDA.reportPublic FDA data

Zephrex D

Product NDC
0113-0401
11-digit product format
001130401
Labeler code
0113
Product ID
0113-0401_28086f51-f7d5-4c69-ad06-49aa164db301
Type
HUMAN OTC DRUG
Nonproprietary name
pseudoephedrine hydrochloride
Dosage form
CAPSULE, GELATIN COATED
Route
ORAL
Labeler
L. Perrigo Company
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2016-11-04
Substance
PSEUDOEPHEDRINE HYDROCHLORIDE
Active strength
30 mg/1
Pharmacologic classes
Adrenergic alpha-Agonists [MoA], alpha-Adrenergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
Zephrex D
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PSEUDOEPHEDRINE HYDROCHLORIDE30 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1430169Internal RxNorm lookup
1918218Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
5468a7e2-361b-494f-9ca3-1b62f3819f65Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
0fdb98e2-b951-a1ce-5715-2b187ba500efProduct name420170718
e974e22d-8688-7d92-1e87-40c1079e170cProduct name320151125
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
0113-0401-62Zephrex D1 in 1 BLISTER PACKCAPSULE, GELATIN COATED15
0113-0401-62Zephrex D24 in 1 CARTONCAPSULE, GELATIN COATED245
0113-0401-67Zephrex D1 in 1 BLISTER PACKCAPSULE, GELATIN COATED15
0113-0401-67Zephrex D48 in 1 CARTONCAPSULE, GELATIN COATED485

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0113-0401-62EA - Each0113-040144f4e884-befd-4206-862f-cf9d09dc39a312021-04-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0113-0401ZEPHREX D (PSEUDOEPHEDRINE HYDROCHLORIDE) CAPSULE, GELATIN COATED [L. PERRIGO COMPANY]5Current NDC, Legacy NDC, 4 package rows20241113_5468a7e2-361b-494f-9ca3-1b62f3819f65.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 143 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
topcare day time cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDETopco Associates LLC1a8e2e03-e11b-4da1-945b-e2caadea72432024-11-07WarningsExact identifier
application number: M012
SUDOGEST NASAL DECONGESTANTPSEUDOEPHEDRINE HCLA-S Medication Solutions09feb5f0-c22d-4a1b-97a0-d5767e5f77302024-11-07WarningsExact identifier
application number: M012
up and up childrens allergy meltsDIPHENHYDRAMINE HCLTarget Corporationf98d1d54-8e11-4bb1-825a-ab5447d378472024-11-07WarningsExact identifier
application number: M012
good sense severe day time cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEL. Perrigo Company44130a1b-63cc-42ac-9590-fdf21a12d1642024-11-07WarningsExact identifier
application number: M012
foster and thrive daytime severe cold and flu reliefACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEStrategic Sourcing Services LLCa5ff1134-8985-4585-8e61-a5fd5f60afeb2024-11-07WarningsExact identifier
application number: M012
basic care daytime severe cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEAmazon.com Services LLC50528d29-ce8c-4efb-a86c-17246b017db02024-11-07WarningsExact identifier
application number: M012
cooling severe daytimeACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDECVS Pharmacyd4a21760-b2bd-4e26-bff0-6fc1b05d26b32024-11-07WarningsExact identifier
application number: M012
dg health day time severe cold and flu reliefACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEDolgencorp, LLC60870311-3234-44ba-95dd-09cf4ea3d5082024-11-07WarningsExact identifier
application number: M012
adult dm max cough and chest congestionDEXTROMETHORPHAN HBR, GUAIFENESINMeijer Distribution Inc3a6855c1-da6d-4fa9-81fe-d2e61355989f2024-11-06WarningsExact identifier
application number: M012
oxymetazoline hclOXYMETAZOLINE HYDROCHLORIDEA-S Medication Solutionse51dfb62-40d0-4bec-9574-90057cb35bcc2024-11-06WarningsExact identifier
application number: M012
Foster and Thrive Adult Tussin DM MAXDEXTROMETHORPHAN HBR, GUAIFENESINStrategic Sourcing Services LLC5f6e4d56-4a66-4dbd-97c8-550310dea3582024-11-05WarningsExact identifier
application number: M012
Cough Drops Honey Lemon with SugarMENTHOLLidl US LLC4ad9398f-7488-6eaf-e054-00144ff8d46c2024-11-05WarningsExact identifier
application number: M012
rexall dm cough and congestion reliefDEXTROMETHORPHAN HBR, GUAIFENESINDolgencorp, LLC906838b1-a742-4728-944d-42b687b8cd592024-11-05WarningsExact identifier
application number: M012
tussinDEXTROMETHORPHAN HBR, GUAIFENESINH E B7c24c59c-7549-4c64-95f8-4bf755cd6f612024-11-05WarningsExact identifier
application number: M012
equate adult tussin dm maxDEXTROMETHORPHAN HBR, GUAIFENESINWal-Mart Stores Inc3592e000-a6c6-47fe-8bb0-9341c65c29592024-11-05WarningsExact identifier
application number: M012
tussin dm maxDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINWalgreen Company756794b0-8d3b-4732-947c-a407caf400e22024-11-05WarningsExact identifier
application number: M012
basic care tussin dm maxDEXTROMETHORPHAN HBR, GUAIFENESINAmazon.com Services LLCc6863e31-e1b9-40ff-ae2e-4aec86b4acc02024-11-05WarningsExact identifier
application number: M012
topcare tussin dm maxDEXTROMETHORPHAN HBR, GUAIFENESINTopco Associates LLC94c35025-7bb4-4cb0-8bf3-4b44bb7fa59a2024-11-05WarningsExact identifier
application number: M012
Childrens Sudafed PE NASAL DECONGESTANTPHENYLEPHRINE HYDROCHLORIDEKenvue Brands LLC4dfd46e4-b9f9-464d-aa47-e8fa9e526a5d2024-11-04WarningsExact identifier
application number: M012
Nighttime Cold and Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATESafeway, Inc.164b2559-2d3f-431e-a03c-07e86731af5c2024-11-04WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1430169pseudoephedrine HCl 30 MG Oral CapsulePSN5468a7e2-361b-494f-9ca3-1b62f3819f655
1918218Zephrex-D 30 MG Oral CapsulePSN5468a7e2-361b-494f-9ca3-1b62f3819f655
1918218pseudoephedrine hydrochloride 30 MG Oral Capsule [Zephrex-D]SBD5468a7e2-361b-494f-9ca3-1b62f3819f655
1430169pseudoephedrine hydrochloride 30 MG Oral CapsuleSCD5468a7e2-361b-494f-9ca3-1b62f3819f655
1918218Zephrex-D 30 MG Oral CapsuleSY5468a7e2-361b-494f-9ca3-1b62f3819f655

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0113-0401-620011304016224 BLISTER PACK in 1 CARTON (0113-0401-62) / 1 CAPSULE, GELATIN COATED in 1 BLISTER PACK24 blister pack2017-04-170000-00-00NoNoCurrent
0113-0401-670011304016748 BLISTER PACK in 1 CARTON (0113-0401-67) / 1 CAPSULE, GELATIN COATED in 1 BLISTER PACK48 blister pack2017-05-080000-00-00NoNoCurrent