Allegra-D Allergy and Congestion 24 HR

Manufacturer: Chattem, Inc.
Effective date: 2026-01-12
Label type: HUMAN OTC DRUG LABEL
Version: 33
Source: monthly-update
Hydrated at: 2026-06-03 17:52:29

Label at a glance#

ProductAllegra-D Allergy and Congestion

Active ingredientFEXOFENADINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDE

Label structure12 sections

Indications and uses

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: ▪ runny nose ▪ sneezing ▪ itchy, watery eyes ▪ itching of the nose or throat temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies reduces swelling of nasal passages temporarily relieves sinus congestion and pressure temporarily restores freer breathing through the nose

Dosage and administration

do not divide, crush, chew or dissolve the tablet; swallow tablet whole adults and children 12 years of age and over take 1 tablet with a glass of water every 24 hours on an empty stomach; do not take more than 1 tablet in 24 hours children under 12 years of age do not use adults 65 years of age and older ask a doctor consumers with kidney disease ask a doctor

Contacts and useful links#

PhoneLabel contact1-800-633-1610

Websitewww.allegra.com

www.allegra.com

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

(in each extended-release tablet)

Fexofenadine HCl 180 mg

Purpose

OTC - PURPOSE SECTION

Antihistamine

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

(in each extended-release tablet)

Pseudoephedrine HCl 240 mg

Purpose

OTC - PURPOSE SECTION

Nasal decongestant

Uses

INDICATIONS & USAGE SECTION

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
▪ runny nose
▪ sneezing
▪ itchy, watery eyes
▪ itching of the nose or throat
temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies
reduces swelling of nasal passages
temporarily relieves sinus congestion and pressure
temporarily restores freer breathing through the nose

Warnings

WARNINGS SECTION

Do not use

OTC - DO NOT USE SECTION

if you have ever had an allergic reaction to this product or any of its ingredients
if you are now taking a prescription monoamine oxidase inhibitor (MAOI)
(certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
If you have difficulty swallowing

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

heart disease
thyroid disease
glaucoma
high blood pressure
diabetes
trouble urinating due to an enlarged prostate gland
kidney disease. Your doctor should determine if you need a different dose.

When using this product

OTC - WHEN USING SECTION

do not take more than directed
do not take at the same time as aluminum or magnesium antacids
do not take with fruit juices (see Directions)
the tablet coating may be seen in the stool (this is normal). Continue to take as directed (see Directions).

Stop use and ask a doctor if

OTC - STOP USE SECTION

an allergic reaction to this product occurs. Seek medical help right away.
symptoms do not improve within 7 days or are accompanied by a fever
you get nervous, dizzy, or sleepless

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

do not divide, crush, chew or dissolve the tablet; swallow tablet whole

adults and children 12 years of age and over	take 1 tablet with a glass of water every 24 hours on an empty stomach; do not take more than 1 tablet in 24 hours
children under 12 years of age	do not use
adults 65 years of age and older	ask a doctor
consumers with kidney disease	ask a doctor

Other information

SPL UNCLASSIFIED SECTION

each tablet contains: sodium 33 mg
safety sealed: do not use if carton is opened or if individual blister units are torn or opened
store between 20º and 25ºC (68º and 77ºF)

Inactive ingredients

INACTIVE INGREDIENT SECTION

acetone, black iron oxide, cellulose acetate, colloidal silicon dioxide, copovidone, croscarmellose sodium, FD&C blue #1 aluminum lake, glycerol triacetate, hypromellose, isopropyl alcohol, magnesium stearate, microcrystalline cellulose, polyethylene glycol, propylene glycol, povidone, sodium chloride, talc, titanium dioxide, water

Questions or comments?

OTC - QUESTIONS SECTION

call toll-free 1-800-633-1610 or www.allegra.com

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 41167-4320-7
NON-DROWSY
Allegra-D^®
ALLERGY & CONGESTION
fexofenadine HCl 180 mg/antihistamine
pseudoephedrine HCl 240 mg/nasal decongestant
Extended Release Tablets
15 Tablets

PRINCIPAL DISPLAY PANEL NDC 41167-4320-7 NON-DROWSY Allegra-D® ALLERGY & CONGESTION fexofenadine HCl 180 mg/antihistamine pseudoephedrine HCl 240 mg/nasal decongestant Extended ...

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
997515	Allegra-D 180 MG / 240 MG 24HR Extended Release Oral Tablet	PSN	33
997415	fexofenadine HCl 180 MG / pseudoephedrine HCl 240 MG 24HR Extended Release Oral Tablet	PSN	33
997515	24 HR fexofenadine hydrochloride 180 MG / pseudoephedrine hydrochloride 240 MG Extended Release Oral Tablet [Allegra-D]	SBD	33
997415	24 HR fexofenadine hydrochloride 180 MG / pseudoephedrine hydrochloride 240 MG Extended Release Oral Tablet	SCD	33
997515	Allegra D 24 HR Allergy & Congestion (fexofenadine hydrochloride 180 MG / pseudoepehedrine hydrochloride 240 MG) Extended Release Oral Tablet	SY	33
997515	Allegra-D 24 Hour (fexofenadine hydrochloride 180 MG / pseudoephedrine hydrochloride 240 MG) Extended Release Oral Tablet	SY	33
997415	fexofenadine hydrochloride 180 MG / pseudoephedrine hydrochloride 240 MG 24 HR Extended Release Oral Tablet	SY	33

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
FEXOFENADINE Pharmacologic Class Indexing	3	Indexing - Pharmacologic Class	20180813
PSEUDOEPHEDRINE Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813

Product Linked Resources#

Resource, Code type, Value table
Resource	Code type	Value	Equivalent identifiers	Source image
Barcode	EAN-13	0041167432075	GTIN-13: 0041167432075 EAN-13: 0041167432075 GTIN-12: 041167432075 UPC-A: 041167432075 GTIN storage (14 digits): 00041167432075	allegra-d-allergy-and-congestion-24-hr-01.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
6c13b22c-b3ba-4127-b768-0132dd5ab0d1	Product name	1	20230829
6bd95106-a412-1dad-b9cc-4cb74bfb27ce	Product name	2	20230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7	Product name	2	20211025
ba088a92-ab5e-b2d4-e908-f5ea691b7587	Product name	7	20210201
e4870509-7e28-6f92-f0be-dd3dd889a9cf	Product name	5	20200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cd	Product name	2	20190619
444b3e50-f226-46ef-bfca-2e7035d140cd	Product name	1	20190611
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
0fdb98e2-b951-a1ce-5715-2b187ba500ef	Product name	4	20170718
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
e974e22d-8688-7d92-1e87-40c1079e170c	Product name	3	20151125
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
290f523a-f9db-9774-b5a9-e1f908ac1782	Product name	1	20150828
e8718272-64cb-4436-969b-176c3067c8f4	Product name	1	20150609
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
30c51294-7ae9-8007-7de6-58222684a0be	Product name	1	20140508
4f26f669-fc6c-40ef-9e26-1c7b2390ee66	Product name	1	20140508
5668b646-cd56-c3c7-bdea-3f6b1a8840db	Product name	1	20140508
684ea482-2e8b-14af-5664-b98f1e402036	Product name	1	20140508
70a83adc-6047-bbea-5a08-dfd304aa47d2	Product name	1	20140508
810ab97e-f109-f41c-7c83-6a652a9cbf43	Product name	1	20140508
858ce051-9941-aafc-8c7c-44a8e0227463	Product name	1	20140508
87711080-88eb-65c5-b2dd-bf99e700a372	Product name	1	20140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2dd	Product name	1	20140508
b060cc1a-fe47-856b-0b77-4448b5963de8	Product name	1	20140508
b893258d-0942-3d8a-3411-056ea0788ff5	Product name	1	20140508
c6b65c52-69c7-df49-550a-a50c137f6218	Product name	1	20140508
ec2149b3-5c6d-5344-f757-c86411073075	Product name	1	20140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
41167-4320-3	Allegra-D Allergy and Congestion	5 in 1 BLISTER PACK	TABLET, FILM COATED, EXTENDED RE	5	33
41167-4320-3	Allegra-D Allergy and Congestion	1 in 1 CARTON	TABLET, FILM COATED, EXTENDED RE	1	33
41167-4320-5	Allegra-D Allergy and Congestion	2 in 1 CARTON	TABLET, FILM COATED, EXTENDED RE	2	33
41167-4320-5	Allegra-D Allergy and Congestion	5 in 1 BLISTER PACK	TABLET, FILM COATED, EXTENDED RE	5	33
41167-4320-7	Allegra-D Allergy and Congestion	3 in 1 CARTON	TABLET, FILM COATED, EXTENDED RE	3	33
41167-4320-7	Allegra-D Allergy and Congestion	5 in 1 BLISTER PACK	TABLET, FILM COATED, EXTENDED RE	5	33

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
41167-4320-3	EA - Each	41167-4320	8821ac71-43a9-40df-af54-7508f3a41a45	1	2012-07-24
41167-4320-5	EA - Each	41167-4320	2beb9aee-f276-48ad-a073-9fd0b7dfa406	1	2012-07-24
41167-4320-7	EA - Each	41167-4320	15273949-82a5-4616-8364-207c7d24b0ad	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
FEXOFENADINE HYDROCHLORIDE	ACTIVE INGREDIENT	2S068B75ZU	14
PSEUDOEPHEDRINE HYDROCHLORIDE	ACTIVE INGREDIENT	6V9V2RYJ8N	14
FEXOFENADINE	ACTIVE MOIETY	E6582LOH6V	14
PSEUDOEPHEDRINE	ACTIVE MOIETY	7CUC9DDI9F	14
ACETONE	INACTIVE INGREDIENT	1364PS73AF	14
ALUMINUM OXIDE	INACTIVE INGREDIENT	LMI26O6933	14
CELLULOSE ACETATE	INACTIVE INGREDIENT	3J2P07GVB6	14
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	14
COPOVIDONE K25-31	INACTIVE INGREDIENT	D9C330MD8B	14
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	14
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	14
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	14
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	14
ISOPROPYL ALCOHOL	INACTIVE INGREDIENT	ND2M416302	14
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	14
METHYL ALCOHOL	INACTIVE INGREDIENT	Y4S76JWI15	14
METHYLENE CHLORIDE	INACTIVE INGREDIENT	588X2YUY0A	14
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	14
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	14
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	14
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	14
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	14
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	14
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	14
TRIACETIN	INACTIVE INGREDIENT	XHX3C3X673	14
WATER	INACTIVE INGREDIENT	059QF0KO0R	14

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 26 matching rows.

Allegra-D Allergy and Congestion
fexofenadine hydrochloride and pseudoephedrine hydrochloride
FEXOFENADINE HYDROCHLORIDE
FEXOFENADINE
PSEUDOEPHEDRINE HYDROCHLORIDE
PSEUDOEPHEDRINE
ALUMINUM OXIDE
TRIACETIN
ACETONE
FERROSOFERRIC OXIDE
CELLULOSE ACETATE
SILICON DIOXIDE
COPOVIDONE K25-31
CROSCARMELLOSE SODIUM
FD&C BLUE NO. 1
HYPROMELLOSES
ISOPROPYL ALCOHOL
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOL, UNSPECIFIED
PROPYLENE GLYCOL
POVIDONE
SODIUM CHLORIDE
TALC
TITANIUM DIOXIDE
WATER

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
41167-4320	41167-4320-3, 41167-4320-5, 41167-4320-7

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 22 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
FEXOFENADINE HYDROCHLORIDE	2S068B75ZU	ACTIB
PSEUDOEPHEDRINE HYDROCHLORIDE	6V9V2RYJ8N	ACTIB
ALUMINUM OXIDE	LMI26O6933	IACT
TRIACETIN	XHX3C3X673	IACT
ACETONE	1364PS73AF	IACT
FERROSOFERRIC OXIDE	XM0M87F357	IACT
CELLULOSE ACETATE	3J2P07GVB6	IACT
SILICON DIOXIDE	ETJ7Z6XBU4	IACT
COPOVIDONE K25-31	D9C330MD8B	IACT
CROSCARMELLOSE SODIUM	M28OL1HH48	IACT
FD&C BLUE NO. 1	H3R47K3TBD	IACT
HYPROMELLOSES	3NXW29V3WO	IACT
ISOPROPYL ALCOHOL	ND2M416302	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
CELLULOSE, MICROCRYSTALLINE	OP1R32D61U	IACT
POLYETHYLENE GLYCOL, UNSPECIFIED	3WJQ0SDW1A	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
POVIDONE	FZ989GH94E	IACT
SODIUM CHLORIDE	451W47IQ8X	IACT
TALC	7SEV7J4R1U	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
WATER	059QF0KO0R	IACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
Version	Effective date	Source	Hydrated
32	2020-12-03	full-release	2026-05-31 23:34:23

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 7 · 388 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
FERROSOFERRIC OXIDE	FERROSOFERRIC OXIDE	XM0M87F357	TABLET / ORAL		2 mg	Exact identifier — unii+route 40 equally ranked IID candidates
CROSCARMELLOSE SODIUM	CROSCARMELLOSE SODIUM	M28OL1HH48	TROCHE / ORAL		50 mg	Exact identifier — unii+route 80 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		53 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
CROSCARMELLOSE SODIUM	CROSCARMELLOSE SODIUM	M28OL1HH48	TROCHE / ORAL		50 mg	Exact identifier — unii+route 80 equally ranked IID candidates
CROSCARMELLOSE SODIUM	CROSCARMELLOSE SODIUM	M28OL1HH48	TABLET, DELAYED RELEASE / ORAL		280 mg	Exact identifier — unii+route 80 equally ranked IID candidates
TRIACETIN	TRIACETIN	XHX3C3X673	CONCENTRATE / ORAL		250 mg	Exact identifier — unii+route 52 equally ranked IID candidates
CROSCARMELLOSE SODIUM	CROSCARMELLOSE SODIUM	M28OL1HH48	TABLET, EXTENDED RELEASE / ORAL		392 mg	Exact identifier — unii+route 80 equally ranked IID candidates
TRIACETIN	TRIACETIN	XHX3C3X673	TABLET, DELAYED RELEASE / ORAL		23 mg	Exact identifier — unii+route 52 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	GRANULE, FOR SUSPENSION / ORAL		162 mg	Exact identifier — unii+route 64 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	CAPSULE, EXTENDED RELEASE / ORAL		41 mg	Exact identifier — unii+route 64 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		615 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	TABLET, FILM COATED / ORAL		100 mg	Exact identifier — unii+route 64 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	TABLET, FILM COATED / ORAL		100 mg	Exact identifier — unii+route 64 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	CAPSULE, COATED PELLETS / ORAL	NA		Exact identifier — unii+route 88 equally ranked IID candidates
CROSCARMELLOSE SODIUM	CROSCARMELLOSE SODIUM	M28OL1HH48	SUSPENSION / ORAL		150 mg	Exact identifier — unii+route 80 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SYRUP / ORAL		40 mg	Exact identifier — unii+route 64 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	CAPSULE, COATED, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii+route 88 equally ranked IID candidates
TRIACETIN	TRIACETIN	XHX3C3X673	CONCENTRATE / ORAL		250 mg	Exact identifier — unii+route 52 equally ranked IID candidates
CROSCARMELLOSE SODIUM	CROSCARMELLOSE SODIUM	M28OL1HH48	PELLET / ORAL		162 mg	Exact identifier — unii+route 80 equally ranked IID candidates
FERROSOFERRIC OXIDE	FERROSOFERRIC OXIDE	XM0M87F357	POWDER, FOR SUSPENSION / ORAL	NA		Exact identifier — unii+route 40 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	TABLET, COATED / ORAL	54.7 mg		Exact identifier — unii+route 64 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	SUSPENSION / ORAL		1 mg	Exact identifier — unii+route 88 equally ranked IID candidates
FERROSOFERRIC OXIDE	FERROSOFERRIC OXIDE	XM0M87F357	TABLET, EXTENDED RELEASE / ORAL		8 mg	Exact identifier — unii+route 40 equally ranked IID candidates
FERROSOFERRIC OXIDE	FERROSOFERRIC OXIDE	XM0M87F357	TABLET, FILM COATED / ORAL	0.2 mg		Exact identifier — unii+route 40 equally ranked IID candidates
POVIDONES	POVIDONE	FZ989GH94E	TABLET, FILM COATED, EXTENDED RELEASE / ORAL	17 mg		Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	CAPSULE, COATED, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii+route 88 equally ranked IID candidates
FERROSOFERRIC OXIDE	FERROSOFERRIC OXIDE	XM0M87F357	CAPSULE, EXTENDED RELEASE / ORAL	1.49 mg		Exact identifier — unii+route 40 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	CAPSULE, EXTENDED RELEASE / ORAL		41 mg	Exact identifier — unii+route 64 equally ranked IID candidates
TRIACETIN	TRIACETIN	XHX3C3X673	TABLET, DELAYED RELEASE / ORAL		23 mg	Exact identifier — unii+route 52 equally ranked IID candidates
FERROSOFERRIC OXIDE	FERROSOFERRIC OXIDE	XM0M87F357	TABLET, DELAYED RELEASE / ORAL		6 mg	Exact identifier — unii+route 40 equally ranked IID candidates
TRIACETIN	TRIACETIN	XHX3C3X673	SUSPENSION, EXTENDED RELEASE / ORAL		4 mg	Exact identifier — unii+route 52 equally ranked IID candidates
FERROSOFERRIC OXIDE	FERROSOFERRIC OXIDE	XM0M87F357	TABLET, FILM COATED / ORAL	0.2 mg		Exact identifier — unii+route 40 equally ranked IID candidates
TRIACETIN	TRIACETIN	XHX3C3X673	CONCENTRATE / ORAL		250 mg	Exact identifier — unii+route 52 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		336 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
CROSCARMELLOSE SODIUM	CROSCARMELLOSE SODIUM	M28OL1HH48	CAPSULE, DELAYED RELEASE / ORAL		72 mg	Exact identifier — unii+route 80 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	LIQUID / ORAL	NA		Exact identifier — unii+route 88 equally ranked IID candidates
CROSCARMELLOSE SODIUM	CROSCARMELLOSE SODIUM	M28OL1HH48	CAPSULE, EXTENDED RELEASE / ORAL		53 mg	Exact identifier — unii+route 80 equally ranked IID candidates
CROSCARMELLOSE SODIUM	CROSCARMELLOSE SODIUM	M28OL1HH48	TABLET, COATED / ORAL		224 mg	Exact identifier — unii+route 80 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	TABLET, ORALLY DISINTEGRATING / ORAL		10 mg	Exact identifier — unii+route 64 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		11 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	TABLET, ORALLY DISINTEGRATING / ORAL		10 mg	Exact identifier — unii+route 64 equally ranked IID candidates
TRIACETIN	TRIACETIN	XHX3C3X673	TABLET, EXTENDED RELEASE / ORAL		26 mg	Exact identifier — unii+route 52 equally ranked IID candidates
CROSCARMELLOSE SODIUM	CROSCARMELLOSE SODIUM	M28OL1HH48	TABLET, CHEWABLE / ORAL		216 mg	Exact identifier — unii+route 80 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	FILM, SOLUBLE / ORAL	0.04 mg		Exact identifier — unii+route 88 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SOLUTION / ORAL		148 mg	Exact identifier — unii+route 64 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	POWDER, FOR SUSPENSION / ORAL	1 mg/5ml		Exact identifier — unii+route 88 equally ranked IID candidates
ACETONE	ACETONE	1364PS73AF	TABLET, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii+route 4 equally ranked IID candidates
CELLULOSE ACETATE	CELLULOSE ACETATE	3J2P07GVB6	CAPSULE / ORAL		186 mg	Exact identifier — unii+route 12 equally ranked IID candidates
CROSCARMELLOSE SODIUM	CROSCARMELLOSE SODIUM	M28OL1HH48	CAPSULE, EXTENDED RELEASE / ORAL		53 mg	Exact identifier — unii+route 80 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		615 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	TABLET, COATED / ORAL	54.7 mg		Exact identifier — unii+route 64 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	TABLET, CHEWABLE / ORAL		20 mg	Exact identifier — unii+route 64 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	POWDER, FOR SUSPENSION / ORAL		98 mg	Exact identifier — unii+route 64 equally ranked IID candidates
CROSCARMELLOSE SODIUM	CROSCARMELLOSE SODIUM	M28OL1HH48	SUSPENSION / ORAL		150 mg	Exact identifier — unii+route 80 equally ranked IID candidates
TRIACETIN	TRIACETIN	XHX3C3X673	TABLET, CHEWABLE, EXTENDED RELEASE / ORAL		2 mg	Exact identifier — unii+route 52 equally ranked IID candidates
CROSCARMELLOSE SODIUM	CROSCARMELLOSE SODIUM	M28OL1HH48	TABLET, FOR SUSPENSION / ORAL		1875 mg	Exact identifier — unii+route 80 equally ranked IID candidates
ACETONE	ACETONE	1364PS73AF	TABLET, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii+route 4 equally ranked IID candidates
FERROSOFERRIC OXIDE	FERROSOFERRIC OXIDE	XM0M87F357	CAPSULE, EXTENDED RELEASE / ORAL	1.49 mg		Exact identifier — unii+route 40 equally ranked IID candidates
CROSCARMELLOSE SODIUM	CROSCARMELLOSE SODIUM	M28OL1HH48	CAPSULE / ORAL		257 mg	Exact identifier — unii+route 80 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SUSPENSION / ORAL		1126 mg	Exact identifier — unii+route 64 equally ranked IID candidates

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N021704-002	ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION	FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE	180MG;240MG	TABLET, EXTENDED RELEASE / ORAL		RLD, RS	2011-01-24

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	N021704-002	ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION	180MG;240MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-01-24	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N021704-002	ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION	180MG;240MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-01-24	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N021704-002	ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION	180MG;240MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-01-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021704-002	ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION	180MG;240MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-01-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021704-002	ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION	180MG;240MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-01-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021704-002	ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION	180MG;240MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-01-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021704-002	ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION	180MG;240MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-01-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021704-002	ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION	180MG;240MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-01-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021704-002	ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION	180MG;240MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-01-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021704-002	ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION	180MG;240MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-01-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021704-002	ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION	180MG;240MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-01-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021704-002	ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION	180MG;240MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-01-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021704-002	ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION	180MG;240MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-01-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021704-002	ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION	180MG;240MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-01-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021704-002	ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION	180MG;240MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-01-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021704-002	ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION	180MG;240MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-01-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021704-002	ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION	180MG;240MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-01-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021704-002	ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION	180MG;240MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-01-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021704-002	ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION	180MG;240MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-01-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021704-002	ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION	180MG;240MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-01-24	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021704-002	ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION	180MG;240MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-01-24	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021704-002	ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION	180MG;240MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-01-24	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021704-002	ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION	180MG;240MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-01-24	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021704-002	ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION	180MG;240MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-01-24	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021704-002	ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION	180MG;240MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-01-24	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021704-002	ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION	180MG;240MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-01-24	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021704-002	ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION	180MG;240MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-01-24	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021704-002	ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION	180MG;240MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-01-24	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021704-002	ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION	180MG;240MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-01-24	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021704-002	ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION	180MG;240MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-01-24	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021704-002	ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION	180MG;240MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-01-24	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021704-002	ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION	180MG;240MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-01-24	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021704-002	ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION	180MG;240MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-01-24	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021704-002	ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION	180MG;240MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-01-24	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021704-002	ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION	180MG;240MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-01-24	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021704-002	ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION	180MG;240MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-01-24	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021704-002	ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION	180MG;240MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-01-24	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021704-002	ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION	180MG;240MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-01-24	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021704-002	ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION	180MG;240MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-01-24	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021704-002	ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION	180MG;240MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-01-24	`3a93d1ddd44b…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N021704-002	6613357	2020-12-25	U-1159	Drug product	2011-07-01	`74a2ff9319b5…`
2020-12-22 03:56 UTC	2020-12	N021704-002	6613357	2020-12-25	U-1159	Drug product	2011-07-01	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021704-002	6613357	2020-12-25	U-1159	Drug product	2011-07-01	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021704-002	6613357	2020-12-25	U-1159	Drug product	2011-07-01	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021704-002	6613357	2020-12-25	U-1159	Drug product	2011-07-01	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021704-002	6613357	2020-12-25	U-1159	Drug product	2011-07-01	`ea99ee380514…`

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Allegra-D Allergy and Congestion	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	Chattem, Inc.	1fb77d6a-fae2-40ae-8f8e-fa2dc66f4403	2026-01-12	Warnings	Exact identifier ndc (package): 41167-4320-3 ndc (package): 41167-4320-5 ndc (package): 41167-4320-7 ndc (product): 41167-4320 ndc11 (package): 41167432005 ndc11 (package): 41167432007 ndc11 (package): 41167432003 spl id: de126d31-d1bb-490f-bf3f-fd9faf4f20ab spl set id: 1fb77d6a-fae2-40ae-8f8e-fa2dc66f4403

Reported adverse events (FAERS/openFDA)#

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