Allegra-D Allergy and Congestion

Product NDC: 41167-4310
Requested package NDC: 41167-4310-6
11-digit product format: 411674310
Labeler code: 41167
Product ID: 41167-4310_9334e66e-cf65-4992-a8c2-9219e48231ec
Type: HUMAN OTC DRUG
Nonproprietary name: fexofenadine hydrochloride and pseudoephedrine hydrochloride
Dosage form: TABLET, FILM COATED, EXTENDED RELEASE
Route: ORAL
Labeler: Chattem, Inc.
Application: NDA020786
Marketing category: NDA
Marketing start: 2011-03-03
Substance: FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE
Active strength: 60; 120 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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
N020786-002	ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION	FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;120MG	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 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N020786-002	ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-01-24	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N020786-002	ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-01-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020786-002	ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-01-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020786-002	ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-01-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020786-002	ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-01-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020786-002	ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-01-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020786-002	ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-01-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020786-002	ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-01-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020786-002	ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-01-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020786-002	ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-01-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020786-002	ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-01-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020786-002	ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-01-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020786-002	ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-01-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020786-002	ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-01-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020786-002	ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-01-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020786-002	ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-01-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020786-002	ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-01-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020786-002	ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-01-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020786-002	ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-01-24	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020786-002	ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-01-24	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020786-002	ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-01-24	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020786-002	ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-01-24	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020786-002	ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-01-24	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020786-002	ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-01-24	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020786-002	ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-01-24	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020786-002	ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-01-24	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020786-002	ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-01-24	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020786-002	ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-01-24	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020786-002	ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-01-24	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020786-002	ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-01-24	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020786-002	ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-01-24	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020786-002	ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-01-24	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020786-002	ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-01-24	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020786-002	ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-01-24	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020786-002	ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-01-24	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020786-002	ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-01-24	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020786-002	ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-01-24	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020786-002	ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-01-24	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020786-002	ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-01-24	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N020786-002	ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-01-24	`f41ea6bd6efb…`

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: Allegra-D Allergy and Congestion
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
FEXOFENADINE HYDROCHLORIDE	60 mg/1
PSEUDOEPHEDRINE HYDROCHLORIDE	120 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2S068B75ZU	Internal UNII lookup
6V9V2RYJ8N	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
997406	Internal RxNorm lookup
997512	Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
b32e172a-abf5-4c17-aa39-19e517952b91	Available on FDA.report

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
41167-4310-2	Allegra-D Allergy and Congestion	1 in 1 CARTON	TABLET, FILM COATED, EXTENDED RE	1	37
41167-4310-2	Allegra-D Allergy and Congestion	10 in 1 BLISTER PACK	TABLET, FILM COATED, EXTENDED RE	10	37
41167-4310-4	Allegra-D Allergy and Congestion	10 in 1 BLISTER PACK	TABLET, FILM COATED, EXTENDED RE	10	37
41167-4310-4	Allegra-D Allergy and Congestion	2 in 1 CARTON	TABLET, FILM COATED, EXTENDED RE	2	37
41167-4310-6	Allegra-D Allergy and Congestion	3 in 1 CARTON	TABLET, FILM COATED, EXTENDED RE	3	37
41167-4310-6	Allegra-D Allergy and Congestion	10 in 1 BLISTER PACK	TABLET, FILM COATED, EXTENDED RE	10	37

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
41167-4310-2	EA - Each	41167-4310	9f74be85-bfd1-4680-89ec-87e62e62d174	1	2012-07-24
41167-4310-4	EA - Each	41167-4310	93e8a5a9-fcf8-4fab-85ff-7dc116314077	1	2012-07-24
41167-4310-6	EA - Each	41167-4310	93cdcecf-d988-4e5d-8112-62fdb61fb1ff	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
FEXOFENADINE HYDROCHLORIDE	ACTIVE INGREDIENT	2S068B75ZU	ALLEGRA D 12 HOUR ALLERGY AND CONGESTION (FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [CHATTEM, INC.]	15
PSEUDOEPHEDRINE HYDROCHLORIDE	ACTIVE INGREDIENT	6V9V2RYJ8N	ALLEGRA D 12 HOUR ALLERGY AND CONGESTION (FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [CHATTEM, INC.]	15
FEXOFENADINE	ACTIVE MOIETY	E6582LOH6V	ALLEGRA D 12 HOUR ALLERGY AND CONGESTION (FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [CHATTEM, INC.]	15
PSEUDOEPHEDRINE	ACTIVE MOIETY	7CUC9DDI9F	ALLEGRA D 12 HOUR ALLERGY AND CONGESTION (FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [CHATTEM, INC.]	15
CARNAUBA WAX	INACTIVE INGREDIENT	R12CBM0EIZ	ALLEGRA D 12 HOUR ALLERGY AND CONGESTION (FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [CHATTEM, INC.]	15
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ALLEGRA D 12 HOUR ALLERGY AND CONGESTION (FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [CHATTEM, INC.]	15
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	ALLEGRA D 12 HOUR ALLERGY AND CONGESTION (FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [CHATTEM, INC.]	15
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	ALLEGRA D 12 HOUR ALLERGY AND CONGESTION (FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [CHATTEM, INC.]	15
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ALLEGRA D 12 HOUR ALLERGY AND CONGESTION (FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [CHATTEM, INC.]	15
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	ALLEGRA D 12 HOUR ALLERGY AND CONGESTION (FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [CHATTEM, INC.]	15
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	ALLEGRA D 12 HOUR ALLERGY AND CONGESTION (FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [CHATTEM, INC.]	15
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	ALLEGRA D 12 HOUR ALLERGY AND CONGESTION (FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [CHATTEM, INC.]	15
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	ALLEGRA D 12 HOUR ALLERGY AND CONGESTION (FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [CHATTEM, INC.]	15
FEXOFENADINE HYDROCHLORIDE	ACTIVE INGREDIENT	2S068B75ZU	ALLEGRA D 12 HOUR ALLERGY AND CONGESTION (FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]	1
PSEUDOEPHEDRINE HYDROCHLORIDE	ACTIVE INGREDIENT	6V9V2RYJ8N	ALLEGRA D 12 HOUR ALLERGY AND CONGESTION (FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]	1
FEXOFENADINE	ACTIVE MOIETY	E6582LOH6V	ALLEGRA D 12 HOUR ALLERGY AND CONGESTION (FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]	1
PSEUDOEPHEDRINE	ACTIVE MOIETY	7CUC9DDI9F	ALLEGRA D 12 HOUR ALLERGY AND CONGESTION (FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]	1
CARNAUBA WAX	INACTIVE INGREDIENT	R12CBM0EIZ	ALLEGRA D 12 HOUR ALLERGY AND CONGESTION (FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ALLEGRA D 12 HOUR ALLERGY AND CONGESTION (FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	ALLEGRA D 12 HOUR ALLERGY AND CONGESTION (FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	ALLEGRA D 12 HOUR ALLERGY AND CONGESTION (FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ALLEGRA D 12 HOUR ALLERGY AND CONGESTION (FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]	1
POLYETHYLENE GLYCOL	INACTIVE INGREDIENT	3WJQ0SDW1A	ALLEGRA D 12 HOUR ALLERGY AND CONGESTION (FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]	1
SILICON DIOXIDE, COLLOIDAL	INACTIVE INGREDIENT	ETJ7Z6XBU4	ALLEGRA D 12 HOUR ALLERGY AND CONGESTION (FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]	1
STARCH, PREGELATINIZED CORN	INACTIVE INGREDIENT	O8232NY3SJ	ALLEGRA D 12 HOUR ALLERGY AND CONGESTION (FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]	1
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	ALLEGRA D 12 HOUR ALLERGY AND CONGESTION (FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
41167-4310	ALLEGRA-D ALLERGY AND CONGESTION (FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [CHATTEM, INC.]	36	Current NDC, Legacy NDC, 6 package rows	20210827_b32e172a-abf5-4c17-aa39-19e517952b91.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 1 · 2 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.	b32e172a-abf5-4c17-aa39-19e517952b91	2026-01-12	Warnings	Exact identifier application applno (NDA): 020786 application number: NDA020786 ndc (package): 41167-4310-6 ndc (product): 41167-4310 ndc11 (package): 41167431006
ALLEGRA-D	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	A-S Medication Solutions	705e1087-61cb-43c3-8675-f56626a1707b	2024-01-07	Warnings	Exact identifier application applno (NDA): 020786 application number: NDA020786

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
2S068B75ZU	FEXOFENADINE HYDROCHLORIDE	153439-40-8	FEXOFENADINE HYDROCHLORIDE
6V9V2RYJ8N	PSEUDOEPHEDRINE HYDROCHLORIDE	345-78-8	PSEUDOEPHEDRINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
997512	Allegra-D 60 MG /120 MG 12HR Extended Release Oral Tablet	PSN	b32e172a-abf5-4c17-aa39-19e517952b91	37
997406	fexofenadine HCl 60 MG / pseudoephedrine HCl 120 MG 12HR Extended Release Oral Tablet	PSN	b32e172a-abf5-4c17-aa39-19e517952b91	37
997512	12 HR fexofenadine hydrochloride 60 MG / pseudoephedrine hydrochloride 120 MG Extended Release Oral Tablet [Allegra-D]	SBD	b32e172a-abf5-4c17-aa39-19e517952b91	37
997406	12 HR fexofenadine hydrochloride 60 MG / pseudoephedrine hydrochloride 120 MG Extended Release Oral Tablet	SCD	b32e172a-abf5-4c17-aa39-19e517952b91	37
997512	Allegra-D 12 Hour (fexofenadine hydrochloride 60 MG / pseudoephedrine hydrochloride 120 MG) Extended Release Oral Tablet	SY	b32e172a-abf5-4c17-aa39-19e517952b91	37
997406	fexofenadine hydrochloride 60 MG / pseudoephedrine hydrochloride 120 MG 12 HR Extended Release Oral Tablet	SY	b32e172a-abf5-4c17-aa39-19e517952b91	37
997512	Allegra-D 60 MG /120 MG 12HR Extended Release Oral Tablet	PSN	705e1087-61cb-43c3-8675-f56626a1707b	12
997406	fexofenadine HCl 60 MG / pseudoephedrine HCl 120 MG 12HR Extended Release Oral Tablet	PSN	705e1087-61cb-43c3-8675-f56626a1707b	12
997512	12 HR fexofenadine hydrochloride 60 MG / pseudoephedrine hydrochloride 120 MG Extended Release Oral Tablet [Allegra-D]	SBD	705e1087-61cb-43c3-8675-f56626a1707b	12
997406	12 HR fexofenadine hydrochloride 60 MG / pseudoephedrine hydrochloride 120 MG Extended Release Oral Tablet	SCD	705e1087-61cb-43c3-8675-f56626a1707b	12
997512	Allegra-D 12 Hour (fexofenadine hydrochloride 60 MG / pseudoephedrine hydrochloride 120 MG) Extended Release Oral Tablet	SY	705e1087-61cb-43c3-8675-f56626a1707b	12
997406	fexofenadine hydrochloride 60 MG / pseudoephedrine hydrochloride 120 MG 12 HR Extended Release Oral Tablet	SY	705e1087-61cb-43c3-8675-f56626a1707b	12
997512	Allegra-D 60 MG /120 MG 12HR Extended Release Oral Tablet	PSN	9ab3a26c-a030-43ff-a68d-f40f1e0c2ab1	1
997406	fexofenadine HCl 60 MG / pseudoephedrine HCl 120 MG 12HR Extended Release Oral Tablet	PSN	9ab3a26c-a030-43ff-a68d-f40f1e0c2ab1	1
997512	12 HR fexofenadine hydrochloride 60 MG / pseudoephedrine hydrochloride 120 MG Extended Release Oral Tablet [Allegra-D]	SBD	9ab3a26c-a030-43ff-a68d-f40f1e0c2ab1	1
997406	12 HR fexofenadine hydrochloride 60 MG / pseudoephedrine hydrochloride 120 MG Extended Release Oral Tablet	SCD	9ab3a26c-a030-43ff-a68d-f40f1e0c2ab1	1
997512	Allegra-D 12 Hour (fexofenadine hydrochloride 60 MG / pseudoephedrine hydrochloride 120 MG) Extended Release Oral Tablet	SY	9ab3a26c-a030-43ff-a68d-f40f1e0c2ab1	1
997406	fexofenadine hydrochloride 60 MG / pseudoephedrine hydrochloride 120 MG 12 HR Extended Release Oral Tablet	SY	9ab3a26c-a030-43ff-a68d-f40f1e0c2ab1	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
41167-4310-6	41167431006	3 BLISTER PACK in 1 CARTON (41167-4310-6) / 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK	3 blister pack	2011-03-03	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Allegra-D Allergy and Congestion 12 HR	Chattem, Inc.	2026-01-12	HUMAN OTC DRUG LABEL	37
ALLEGRA-D	A-S Medication Solutions	2024-01-07	HUMAN OTC DRUG LABEL	12
Allegra-D 12 Hour Allergy and Congestion	Rebel Distributors Corp	2011-07-20	HUMAN OTC DRUG LABEL	1