FDA.reportPublic FDA data

Nasal Decongestant

Product NDC
68016-473
11-digit product format
680160473
Labeler code
68016
Product ID
68016-473_fc83b1ed-bf6b-4bf4-9bcc-365973e7d30d
Type
HUMAN OTC DRUG
Nonproprietary name
Pseudoephedrine HCl
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Chain Drug Consortium
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
1981-08-25
Marketing end
2027-08-31
Substance
PSEUDOEPHEDRINE HYDROCHLORIDE
Active strength
30 mg/1
Pharmacologic classes
Adrenergic alpha-Agonists [MoA], alpha-Adrenergic Agonist [EPC]
NDC exclude flag
No
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
Nasal Decongestant
Brand name suffix
Maximum Strength

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 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1049160Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
270e9221-d305-4148-b523-741e02fe733fAvailable 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
68016-473-24Nasal DecongestantMaximum Strength1 in 1 CARTONTABLET, FILM COATED114
68016-473-24Nasal DecongestantMaximum Strength24 in 1 BLISTER PACKTABLET, FILM COATED2414
68016-473-96Nasal DecongestantMaximum Strength4 in 1 CARTONTABLET, FILM COATED414
68016-473-96Nasal DecongestantMaximum Strength24 in 1 BLISTER PACKTABLET, FILM COATED2414

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PSEUDOEPHEDRINE HYDROCHLORIDEACTIVE INGREDIENT6V9V2RYJ8NNASAL DECONGESTANT MAXIMUM STRENGTH (PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [CHAIN DRUG CONSORTIUM]1
PSEUDOEPHEDRINEACTIVE MOIETY7CUC9DDI9FNASAL DECONGESTANT MAXIMUM STRENGTH (PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [CHAIN DRUG CONSORTIUM]1
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENTL11K75P92JNASAL DECONGESTANT MAXIMUM STRENGTH (PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [CHAIN DRUG CONSORTIUM]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UNASAL DECONGESTANT MAXIMUM STRENGTH (PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [CHAIN DRUG CONSORTIUM]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48NASAL DECONGESTANT MAXIMUM STRENGTH (PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [CHAIN DRUG CONSORTIUM]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOANASAL DECONGESTANT MAXIMUM STRENGTH (PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [CHAIN DRUG CONSORTIUM]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8NASAL DECONGESTANT MAXIMUM STRENGTH (PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [CHAIN DRUG CONSORTIUM]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WONASAL DECONGESTANT MAXIMUM STRENGTH (PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [CHAIN DRUG CONSORTIUM]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30NASAL DECONGESTANT MAXIMUM STRENGTH (PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [CHAIN DRUG CONSORTIUM]1
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IENASAL DECONGESTANT MAXIMUM STRENGTH (PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [CHAIN DRUG CONSORTIUM]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ANASAL DECONGESTANT MAXIMUM STRENGTH (PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [CHAIN DRUG CONSORTIUM]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPNASAL DECONGESTANT MAXIMUM STRENGTH (PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [CHAIN DRUG CONSORTIUM]1
TRIACETININACTIVE INGREDIENTXHX3C3X673NASAL DECONGESTANT MAXIMUM STRENGTH (PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [CHAIN DRUG CONSORTIUM]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68016-473NASAL DECONGESTANT MAXIMUM STRENGTH (PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [CHAIN DRUG CONSORTIUM]13Current NDC, Legacy NDC, 4 package rows20250309_270e9221-d305-4148-b523-741e02fe733f.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 102 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AXIV NightTimeACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEVIVUNT PHARMA LLC131f6314-c9a1-7af3-e063-6294a90abe6f2025-09-17WarningsExact identifier
application number: M012
AXIV DayTime - NightTime 48 SoftgelsACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEVIVUNT PHARMA LLC1320e243-344f-98ed-e063-6294a90a00922025-09-17WarningsExact identifier
application number: M012
AXIV Sinus Severe MucusACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HYDROCLORIDEVIVUNT PHARMA LLC13245298-8b78-e177-e063-6294a90a6bec2025-09-17WarningsExact identifier
application number: M012
GoodSense Tussin CF Multi-Symptom Cold, RaspberryDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLGeiss, Destin & Dunn Inc.3f05cf84-d485-7688-e063-6394a90ae7402025-09-17WarningsExact identifier
application number: M012
Daytime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLFamily Dollar (FAMILY WELLNESS)5d7466b4-fdb7-432b-880d-e7aa4a4acbda2025-09-17WarningsExact identifier
application number: M012
allergy relief ChildrensDIPHENHYDRAMINE HCLUnited Natural Foods, Inc. dba UNFIe34d8bf5-e12e-453c-93ea-9c7988c4f13d2025-09-16WarningsExact identifier
application number: M012
DayTime Cold Flu Non DrowsyACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEHarris Teeter, LLC67beb9f6-4e0a-4f7b-b50a-4bcd3a01354f2025-09-16WarningsExact identifier
application number: M012
DOMETUSSCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDEDomel Laboratories3ebfc62f-27f6-48b2-9bae-bdefbd1d05fe2025-09-16WarningsExact identifier
application number: M012
CareOne Severe Congestion NasalOXYMETAZOLINE HYDROCHLORIDEAmerican Sales Companyd1dba68b-c4e1-4afc-9aee-6a51341b89f52025-09-16WarningsExact identifier
application number: M012
Daytime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLFSA Store Inc. (Caring Mills)e69ef8dc-09d2-46de-aebf-ba735f4cc7ea2025-09-16WarningsExact identifier
application number: M012
Menthol Cough Drops Honey Lemon FlavorMENTHOL HONEY LEMON FLAVORCVS Pharmacy3ea9a1f2-75b3-c67a-e063-6294a90a8caf2025-09-13WarningsExact identifier
application number: M012
Menthol Cough Drops Honey Lemon FlavorMENTHOL HONEY LEMON FLAVORCVS Pharmacy3eab4cf9-6fdc-a6fb-e063-6394a90a86332025-09-13WarningsExact identifier
application number: M012
COLD AND FLU DAYTIME-NIGHTTIMEACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLTARGET CORP9de9fab3-890a-158d-e053-2a95a90af4232025-09-13WarningsExact identifier
application number: M012
Diphenhydramine HydrochlorideDIPHENHYDRAMINE HYDROCHLORIDEPrecision Dose, Inc.4d0f4f5b-3135-4457-bb8f-ad9d28ca5ea42025-09-12WarningsExact identifier
application number: M012
Nasal Spray, Circle KOXYMETAZOLINE HYDROCHLORIDE 0.05% SOLUTIONLil' Drug Store Products, Inc.3ea06e88-a2c6-621b-e063-6294a90a10752025-09-12WarningsExact identifier
application number: M012
Daytime Nighttime Cold Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLHarris Teeter, LLCa0090dc6-0fe5-4ab2-a2cf-6ed19892f3632025-09-12WarningsExact identifier
application number: M012
Multi Symptom Cold and Multi Symptom Nighttime Cold ChildrensDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCI, ACETAMINOPHEN, DIPHENHYDRAMINE HCI, PHENYLEPHRINE HCICVS Pharmacyebf2dbb4-96fa-4bf6-9afd-8aa8b5369f2e2025-09-12WarningsExact identifier
application number: M012
Daytime Nighttime Cold Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLFSA Store Inc. (Caring Mills)8d7bb31b-a47d-4252-a0a7-79d286179fb92025-09-12WarningsExact identifier
application number: M012
Daytime Nighttime Cold Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLFamily Dollar (FAMILY WELLNESS)150e5c3a-7c86-4b66-af30-a376df6974012025-09-12WarningsExact identifier
application number: M012
SEVERE COUGH COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED67f8d405-a2ad-4ade-93b4-9b09a0d81d8e2025-09-11WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049160pseudoephedrine HCl 30 MG Oral TabletPSN270e9221-d305-4148-b523-741e02fe733f14
1049160pseudoephedrine hydrochloride 30 MG Oral TabletSCD270e9221-d305-4148-b523-741e02fe733f14

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68016-473-24680160473241 BLISTER PACK in 1 CARTON (68016-473-24) / 24 TABLET, FILM COATED in 1 BLISTER PACK1 blister pack1981-08-252027-08-31NoNoCurrent
68016-473-96680160473964 BLISTER PACK in 1 CARTON (68016-473-96) / 24 TABLET, FILM COATED in 1 BLISTER PACK4 blister pack1981-08-252027-08-31NoNoCurrent