Claritin-D

Manufacturer: Bayer HealthCare LLC.
Effective date: 2025-12-05
Label type: HUMAN OTC DRUG LABEL
Version: 10
Source: full-release
Hydrated at: 2026-06-01 01:20:22

Label at a glance#

ProductClaritin-D 12 Hour

Active ingredientLORATADINE, PSEUDOEPHEDRINE SULFATE

Label structure9 sections

Indications and uses

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: sneezing itchy, watery eyes runny nose 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 adults and children 12 years and over 1 tablet every 12 hours; not more than 2 tablets in 24 hours children under 12 years of age ask a doctor consumers with liver or kidney disease ask a doctor

Storage and handling

each tablet contains: calcium 30 mg safety sealed: do not use if the individual blister unit imprinted with Claritin-D ® 12 Hour is open or torn store between 20° to 25°C (68° to 77°F) keep in a dry place

Contacts and useful links#

PhoneLabel contact1-800-252-7484

Websitewww.claritin.com

www.claritin.com

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredient (in each tablet)	Purpose
Loratadine 5 mg	Antihistamine
Pseudoephedrine sulfate 120 mg	Nasal decongestant

Uses

INDICATIONS & USAGE SECTION

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
- sneezing
- itchy, watery eyes
- runny nose
- 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

OTC - DO NOT USE SECTION

Do not use

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.

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have

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

OTC - WHEN USING SECTION

When using this product do not take more than directed.

Taking more than directed may cause drowsiness.

OTC - STOP USE SECTION

Stop use and ask a doctor if

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
nervousness, dizziness or sleeplessness occurs

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. 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

adults and children 12 years and over	1 tablet every 12 hours; not more than 2 tablets in 24 hours
children under 12 years of age	ask a doctor
consumers with liver or kidney disease	ask a doctor

Other information

STORAGE AND HANDLING SECTION

each tablet contains: calcium 30 mg
safety sealed: do not use if the individual blister unit imprinted with Claritin-D ^® 12 Hour is open or torn
store between 20° to 25°C (68° to 77°F)
keep in a dry place

Inactive ingredients

INACTIVE INGREDIENT SECTION

croscarmellose sodium, dibasic calcium phosphate, hypromellose, lactose monohydrate, magnesium sterarate, pharmaceutical ink, povidone, titanium dioxide

Questions or comments?

OTC - QUESTIONS SECTION

1-800-CLARITIN (1-800-252-7484) or www.claritin.com

PRINCIPAL DISPLAY PANEL - Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 11523-7162-1

Non-Drowsy*

Claritin-D^®

pseudoephedrine sulfate 120 mg/nasal decongestant

loratadine 5 mg/antihistamine

Indoor & Outdoor Allergies

Allergy & Congestion

12

Hour

Relief of:

Nasal & Sinus Congestion

Due to Colds or Allergies

Sneezing; Runny Nose;

Itchy, Watery Eyes;

Itchy Throat or Nose

Due to Allergies

* When taken as directed. See Drug Facts Panel.

10

EXTENDED

RELEASE TABLETS

Carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1242406	Claritin-D 5 MG / 120 MG 12HR Extended Release Oral Tablet	PSN	10
1242399	pseudoephedrine sulfate 120 MG / loratadine 5 MG 12HR Extended Release Oral Tablet	PSN	10
1242406	12 HR loratadine 5 MG / pseudoephedrine sulfate 120 MG Extended Release Oral Tablet [Claritin-D]	SBD	10
1242399	12 HR loratadine 5 MG / pseudoephedrine sulfate 120 MG Extended Release Oral Tablet	SCD	10
1242406	Claritin-D (loratadine 5 MG / pseudoephedrine sulfate 120 MG) 12 HR Extended Release Oral Tablet	SY	10
1242399	loratadine 5 MG / pseudoephedrine sulfate 120 MG 12 HR Extended Release Oral Tablet	SY	10

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
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	0041100802088	GTIN-13: 0041100802088 EAN-13: 0041100802088 GTIN-12: 041100802088 UPC-A: 041100802088 GTIN storage (14 digits): 00041100802088	Claritin_D_12hr_10ct_Carton.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
ba088a92-ab5e-b2d4-e908-f5ea691b7587	Product name	7	20210201
0fdb98e2-b951-a1ce-5715-2b187ba500ef	Product name	4	20170718
e974e22d-8688-7d92-1e87-40c1079e170c	Product name	3	20151125
e8718272-64cb-4436-969b-176c3067c8f4	Product name	1	20150609
30c51294-7ae9-8007-7de6-58222684a0be	Product name	1	20140508
4f26f669-fc6c-40ef-9e26-1c7b2390ee66	Product name	1	20140508
70a83adc-6047-bbea-5a08-dfd304aa47d2	Product name	1	20140508
858ce051-9941-aafc-8c7c-44a8e0227463	Product name	1	20140508
b893258d-0942-3d8a-3411-056ea0788ff5	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
11523-7162-1	Claritin-D12 Hour	10 in 1 BLISTER PACK	TABLET, EXTENDED RELEASE	10	10
11523-7162-1	Claritin-D12 Hour	1 in 1 CARTON	TABLET, EXTENDED RELEASE	1	10
11523-7162-2	Claritin-D12 Hour	2 in 1 CARTON	TABLET, EXTENDED RELEASE	2	10
11523-7162-2	Claritin-D12 Hour	10 in 1 BLISTER PACK	TABLET, EXTENDED RELEASE	10	10
11523-7162-3	Claritin-D12 Hour	3 in 1 CARTON	TABLET, EXTENDED RELEASE	3	10
11523-7162-3	Claritin-D12 Hour	10 in 1 BLISTER PACK	TABLET, EXTENDED RELEASE	10	10

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
11523-7162-1	EA - Each	11523-7162	85cce7f3-cec5-4281-aaa0-08796678607d	1	2012-07-24
11523-7162-2	EA - Each	11523-7162	c215d904-7907-4d87-a34a-651e85e00f12	1	2012-07-24
11523-7162-3	EA - Each	11523-7162	a7d669e2-7d96-4d35-9050-886853111333	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
Loratadine	ACTIVE INGREDIENT	7AJO3BO7QN	2
pseudoephedrine sulfate	ACTIVE INGREDIENT	Y9DL7QPE6B	2
Loratadine	ACTIVE MOIETY	7AJO3BO7QN	2
pseudoephedrine	ACTIVE MOIETY	7CUC9DDI9F	2
calcium phosphate, dibasic, anhydrous	INACTIVE INGREDIENT	L11K75P92J	2
croscarmellose sodium	INACTIVE INGREDIENT	M28OL1HH48	2
hypromelloses	INACTIVE INGREDIENT	3NXW29V3WO	2
lactose monohydrate	INACTIVE INGREDIENT	EWQ57Q8I5X	2
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	2
povidones	INACTIVE INGREDIENT	FZ989GH94E	2
titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	2

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

Claritin-D 12 Hour
Loratadine and pseudoephedrine sulfate
CROSCARMELLOSE SODIUM
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS
HYPROMELLOSES
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
POVIDONE
TITANIUM DIOXIDE
LORATADINE
PSEUDOEPHEDRINE SULFATE
PSEUDOEPHEDRINE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
11523-7162	11523-7162-1, 11523-7162-2, 11523-7162-3

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
CROSCARMELLOSE SODIUM	M28OL1HH48	IACT
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS	L11K75P92J	IACT
HYPROMELLOSES	3NXW29V3WO	IACT
LACTOSE MONOHYDRATE	EWQ57Q8I5X	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
POVIDONE	FZ989GH94E	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
LORATADINE	7AJO3BO7QN	ACTIB
PSEUDOEPHEDRINE SULFATE	Y9DL7QPE6B	ACTIB

Source Document#

Source XML

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 1 · 28 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Maximum daily exposure	Match
lactose monohydrate	LACTOSE MONOHYDRATE	EWQ57Q8I5X	TABLET, EXTENDED RELEASE / ORAL	2575 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
lactose monohydrate	LACTOSE MONOHYDRATE	EWQ57Q8I5X	TABLET, EXTENDED RELEASE / ORAL	2575 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
croscarmellose sodium	CROSCARMELLOSE SODIUM	M28OL1HH48	TABLET, EXTENDED RELEASE / ORAL	392 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
titanium dioxide	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, EXTENDED RELEASE / ORAL	90 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
magnesium stearate	MAGNESIUM STEARATE	70097M6I30	TABLET, EXTENDED RELEASE / ORAL	173 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
croscarmellose sodium	CROSCARMELLOSE SODIUM	M28OL1HH48	TABLET, EXTENDED RELEASE / ORAL	392 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
hypromelloses	HYPROMELLOSE	3NXW29V3WO	TABLET, EXTENDED RELEASE / ORAL	1472 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
calcium phosphate, dibasic, anhydrous	ANHYDROUS DIBASIC CALCIUM PHOSPHATE	L11K75P92J	TABLET, EXTENDED RELEASE / ORAL	360 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
hypromelloses	HYPROMELLOSE	3NXW29V3WO	TABLET, EXTENDED RELEASE / ORAL	1472 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
lactose monohydrate	LACTOSE MONOHYDRATE	EWQ57Q8I5X	TABLET, EXTENDED RELEASE / ORAL	2575 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
magnesium stearate	MAGNESIUM STEARATE	70097M6I30	TABLET, EXTENDED RELEASE / ORAL	173 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
titanium dioxide	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, EXTENDED RELEASE / ORAL	90 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
hypromelloses	HYPROMELLOSE	3NXW29V3WO	TABLET, EXTENDED RELEASE / ORAL	1472 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
titanium dioxide	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, EXTENDED RELEASE / ORAL	90 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
hypromelloses	HYPROMELLOSE	3NXW29V3WO	TABLET, EXTENDED RELEASE / ORAL	1472 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
povidones	POVIDONE	FZ989GH94E	TABLET, EXTENDED RELEASE / ORAL	101 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
magnesium stearate	MAGNESIUM STEARATE	70097M6I30	TABLET, EXTENDED RELEASE / ORAL	173 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
calcium phosphate, dibasic, anhydrous	ANHYDROUS DIBASIC CALCIUM PHOSPHATE	L11K75P92J	TABLET, EXTENDED RELEASE / ORAL	360 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
magnesium stearate	MAGNESIUM STEARATE	70097M6I30	TABLET, EXTENDED RELEASE / ORAL	173 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
croscarmellose sodium	CROSCARMELLOSE SODIUM	M28OL1HH48	TABLET, EXTENDED RELEASE / ORAL	392 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
povidones	POVIDONE	FZ989GH94E	TABLET, EXTENDED RELEASE / ORAL	101 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
titanium dioxide	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, EXTENDED RELEASE / ORAL	90 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
lactose monohydrate	LACTOSE MONOHYDRATE	EWQ57Q8I5X	TABLET, EXTENDED RELEASE / ORAL	2575 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
croscarmellose sodium	CROSCARMELLOSE SODIUM	M28OL1HH48	TABLET, EXTENDED RELEASE / ORAL	392 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
calcium phosphate, dibasic, anhydrous	ANHYDROUS DIBASIC CALCIUM PHOSPHATE	L11K75P92J	TABLET, EXTENDED RELEASE / ORAL	360 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
povidones	POVIDONE	FZ989GH94E	TABLET, EXTENDED RELEASE / ORAL	101 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
calcium phosphate, dibasic, anhydrous	ANHYDROUS DIBASIC CALCIUM PHOSPHATE	L11K75P92J	TABLET, EXTENDED RELEASE / ORAL	360 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
povidones	POVIDONE	FZ989GH94E	TABLET, EXTENDED RELEASE / ORAL	101 mg	Exact identifier — unii+route+dosage form 4 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
N019670-002	CLARITIN-D	LORATADINE; PSEUDOEPHEDRINE SULFATE	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL		RLD, RS	2002-11-27

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	N019670-002	CLARITIN-D	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-11-27	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N019670-002	CLARITIN-D	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-11-27	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N019670-002	CLARITIN-D	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-11-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N019670-002	CLARITIN-D	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-11-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019670-002	CLARITIN-D	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-11-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019670-002	CLARITIN-D	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-11-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019670-002	CLARITIN-D	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-11-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019670-002	CLARITIN-D	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-11-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019670-002	CLARITIN-D	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-11-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019670-002	CLARITIN-D	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-11-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019670-002	CLARITIN-D	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-11-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019670-002	CLARITIN-D	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-11-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N019670-002	CLARITIN-D	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-11-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019670-002	CLARITIN-D	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-11-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019670-002	CLARITIN-D	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-11-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019670-002	CLARITIN-D	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-11-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N019670-002	CLARITIN-D	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-11-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019670-002	CLARITIN-D	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-11-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N019670-002	CLARITIN-D	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-11-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N019670-002	CLARITIN-D	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-11-27	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N019670-002	CLARITIN-D	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-11-27	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N019670-002	CLARITIN-D	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-11-27	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N019670-002	CLARITIN-D	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-11-27	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N019670-002	CLARITIN-D	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-11-27	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N019670-002	CLARITIN-D	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-11-27	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N019670-002	CLARITIN-D	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-11-27	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N019670-002	CLARITIN-D	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-11-27	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N019670-002	CLARITIN-D	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-11-27	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N019670-002	CLARITIN-D	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-11-27	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N019670-002	CLARITIN-D	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-11-27	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N019670-002	CLARITIN-D	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-11-27	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N019670-002	CLARITIN-D	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-11-27	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N019670-002	CLARITIN-D	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-11-27	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N019670-002	CLARITIN-D	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-11-27	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N019670-002	CLARITIN-D	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-11-27	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N019670-002	CLARITIN-D	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-11-27	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N019670-002	CLARITIN-D	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-11-27	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N019670-002	CLARITIN-D	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-11-27	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N019670-002	CLARITIN-D	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-11-27	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N019670-002	CLARITIN-D	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-11-27	`3a93d1ddd44b…`

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
Claritin-D 12 Hour	LORATADINE AND PSEUDOEPHEDRINE SULFATE	Bayer HealthCare LLC.	a7125705-01ff-4418-8c53-9209c2bbb484	2025-12-05	Warnings	Exact identifier ndc (package): 11523-7162-2 ndc (package): 11523-7162-1 ndc (package): 11523-7162-3 ndc (product): 11523-7162 ndc11 (package): 11523716203 ndc11 (package): 11523716201 ndc11 (package): 11523716202 spl id: 45371982-daab-f344-e063-6394a90a2f41 spl set id: a7125705-01ff-4418-8c53-9209c2bbb484

Reported adverse events (FAERS/openFDA)#

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