nasal decongestant

Product NDC: 41250-432
11-digit product format: 412500432
Labeler code: 41250
Product ID: 41250-432_b8e8c96e-f746-4bc1-9bc9-16c49b37885b
Type: HUMAN OTC DRUG
Nonproprietary name: Pseudoephedrine HCl
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Meijer Distribution Inc
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 1991-02-15
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: 2027-12-31
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: nasal decongestant
Brand name suffix: maximum strength non drowsy
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
PSEUDOEPHEDRINE HYDROCHLORIDE	30 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1049160	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
8a68ca99-fd76-409a-9769-88830e8720a8	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
41250-432-62	nasal decongestantmaximum strength non drowsy	1 in 1 BLISTER PACK	TABLET, FILM COATED	1	5
41250-432-62	nasal decongestantmaximum strength non drowsy	24 in 1 CARTON	TABLET, FILM COATED	24	5
41250-432-67	nasal decongestantmaximum strength non drowsy	1 in 1 BLISTER PACK	TABLET, FILM COATED	1	5
41250-432-67	nasal decongestantmaximum strength non drowsy	48 in 1 CARTON	TABLET, FILM COATED	48	5
41250-432-80	nasal decongestantmaximum strength non drowsy	96 in 1 CARTON	TABLET, FILM COATED	96	5
41250-432-80	nasal decongestantmaximum strength non drowsy	1 in 1 BLISTER PACK	TABLET, FILM COATED	1	5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
41250-432-67	EA - Each	41250-432	eca29067-3ea4-4dc7-98f0-aa840f3f0809	1	2024-05-16

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
PSEUDOEPHEDRINE HYDROCHLORIDE	ACTIVE INGREDIENT	6V9V2RYJ8N	NASAL DECONGESTANT MAXIMUM STRENGTH NON DROWSY (PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [MEIJER DISTRIBUTION INC]	1
PSEUDOEPHEDRINE	ACTIVE MOIETY	7CUC9DDI9F	NASAL DECONGESTANT MAXIMUM STRENGTH NON DROWSY (PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [MEIJER DISTRIBUTION INC]	1
ANHYDROUS DIBASIC CALCIUM PHOSPHATE	INACTIVE INGREDIENT	L11K75P92J	NASAL DECONGESTANT MAXIMUM STRENGTH NON DROWSY (PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [MEIJER DISTRIBUTION INC]	1
CARNAUBA WAX	INACTIVE INGREDIENT	R12CBM0EIZ	NASAL DECONGESTANT MAXIMUM STRENGTH NON DROWSY (PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [MEIJER DISTRIBUTION INC]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	NASAL DECONGESTANT MAXIMUM STRENGTH NON DROWSY (PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [MEIJER DISTRIBUTION INC]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	NASAL DECONGESTANT MAXIMUM STRENGTH NON DROWSY (PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [MEIJER DISTRIBUTION INC]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	NASAL DECONGESTANT MAXIMUM STRENGTH NON DROWSY (PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [MEIJER DISTRIBUTION INC]	1
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	NASAL DECONGESTANT MAXIMUM STRENGTH NON DROWSY (PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [MEIJER DISTRIBUTION INC]	1
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	NASAL DECONGESTANT MAXIMUM STRENGTH NON DROWSY (PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [MEIJER DISTRIBUTION INC]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	NASAL DECONGESTANT MAXIMUM STRENGTH NON DROWSY (PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [MEIJER DISTRIBUTION INC]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	NASAL DECONGESTANT MAXIMUM STRENGTH NON DROWSY (PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [MEIJER DISTRIBUTION INC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
41250-432	NASAL DECONGESTANT MAXIMUM STRENGTH NON DROWSY (PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [MEIJER DISTRIBUTION INC]	5	Current NDC, Legacy NDC, 6 package rows	20241011_8a68ca99-fd76-409a-9769-88830e8720a8.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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
AXIV NightTime	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	VIVUNT PHARMA LLC	131f6314-c9a1-7af3-e063-6294a90abe6f	2025-09-17	Warnings	Exact identifier application number: M012
AXIV DayTime - NightTime 48 Softgels	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	VIVUNT PHARMA LLC	1320e243-344f-98ed-e063-6294a90a0092	2025-09-17	Warnings	Exact identifier application number: M012
AXIV Sinus Severe Mucus	ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HYDROCLORIDE	VIVUNT PHARMA LLC	13245298-8b78-e177-e063-6294a90a6bec	2025-09-17	Warnings	Exact identifier application number: M012
GoodSense Tussin CF Multi-Symptom Cold, Raspberry	DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Geiss, Destin & Dunn Inc.	3f05cf84-d485-7688-e063-6394a90ae740	2025-09-17	Warnings	Exact identifier application number: M012
Daytime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Family Dollar (FAMILY WELLNESS)	5d7466b4-fdb7-432b-880d-e7aa4a4acbda	2025-09-17	Warnings	Exact identifier application number: M012
allergy relief Childrens	DIPHENHYDRAMINE HCL	United Natural Foods, Inc. dba UNFI	e34d8bf5-e12e-453c-93ea-9c7988c4f13d	2025-09-16	Warnings	Exact identifier application number: M012
DayTime Cold Flu Non Drowsy	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	Harris Teeter, LLC	67beb9f6-4e0a-4f7b-b50a-4bcd3a01354f	2025-09-16	Warnings	Exact identifier application number: M012
DOMETUSS	CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE	Domel Laboratories	3ebfc62f-27f6-48b2-9bae-bdefbd1d05fe	2025-09-16	Warnings	Exact identifier application number: M012
CareOne Severe Congestion Nasal	OXYMETAZOLINE HYDROCHLORIDE	American Sales Company	d1dba68b-c4e1-4afc-9aee-6a51341b89f5	2025-09-16	Warnings	Exact identifier application number: M012
Daytime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	FSA Store Inc. (Caring Mills)	e69ef8dc-09d2-46de-aebf-ba735f4cc7ea	2025-09-16	Warnings	Exact identifier application number: M012
Menthol Cough Drops Honey Lemon Flavor	MENTHOL HONEY LEMON FLAVOR	CVS Pharmacy	3ea9a1f2-75b3-c67a-e063-6294a90a8caf	2025-09-13	Warnings	Exact identifier application number: M012
Menthol Cough Drops Honey Lemon Flavor	MENTHOL HONEY LEMON FLAVOR	CVS Pharmacy	3eab4cf9-6fdc-a6fb-e063-6394a90a8633	2025-09-13	Warnings	Exact identifier application number: M012
COLD AND FLU DAYTIME-NIGHTTIME	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	TARGET CORP	9de9fab3-890a-158d-e053-2a95a90af423	2025-09-13	Warnings	Exact identifier application number: M012
Diphenhydramine Hydrochloride	DIPHENHYDRAMINE HYDROCHLORIDE	Precision Dose, Inc.	4d0f4f5b-3135-4457-bb8f-ad9d28ca5ea4	2025-09-12	Warnings	Exact identifier application number: M012
Nasal Spray, Circle K	OXYMETAZOLINE HYDROCHLORIDE 0.05% SOLUTION	Lil' Drug Store Products, Inc.	3ea06e88-a2c6-621b-e063-6294a90a1075	2025-09-12	Warnings	Exact identifier application number: M012
Daytime Nighttime Cold Flu Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	Harris Teeter, LLC	a0090dc6-0fe5-4ab2-a2cf-6ed19892f363	2025-09-12	Warnings	Exact identifier application number: M012
Multi Symptom Cold and Multi Symptom Nighttime Cold Childrens	DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCI, ACETAMINOPHEN, DIPHENHYDRAMINE HCI, PHENYLEPHRINE HCI	CVS Pharmacy	ebf2dbb4-96fa-4bf6-9afd-8aa8b5369f2e	2025-09-12	Warnings	Exact identifier application number: M012
Daytime Nighttime Cold Flu Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	FSA Store Inc. (Caring Mills)	8d7bb31b-a47d-4252-a0a7-79d286179fb9	2025-09-12	Warnings	Exact identifier application number: M012
Daytime Nighttime Cold Flu Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	Family Dollar (FAMILY WELLNESS)	150e5c3a-7c86-4b66-af30-a376df697401	2025-09-12	Warnings	Exact identifier application number: M012
SEVERE COUGH COLD AND FLU	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	67f8d405-a2ad-4ade-93b4-9b09a0d81d8e	2025-09-11	Warnings	Exact identifier application number: M012

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
6V9V2RYJ8N	PSEUDOEPHEDRINE HYDROCHLORIDE	345-78-8	PSEUDOEPHEDRINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1049160	pseudoephedrine HCl 30 MG Oral Tablet	PSN	8a68ca99-fd76-409a-9769-88830e8720a8	5
1049160	pseudoephedrine hydrochloride 30 MG Oral Tablet	SCD	8a68ca99-fd76-409a-9769-88830e8720a8	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
41250-432-62	41250043262	24 BLISTER PACK in 1 CARTON (41250-432-62) / 1 TABLET, FILM COATED in 1 BLISTER PACK	24 blister pack	1991-02-15	0000-00-00	No	No	Current
41250-432-67	41250043267	48 BLISTER PACK in 1 CARTON (41250-432-67) / 1 TABLET, FILM COATED in 1 BLISTER PACK	48 blister pack	1995-11-09	0000-00-00	No	No	Current
41250-432-80	41250043280	96 BLISTER PACK in 1 CARTON (41250-432-80) / 1 TABLET, FILM COATED in 1 BLISTER PACK	96 blister pack	1997-08-14	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Meijer Distribution, Inc. Nasal Decongestant Drug Facts	Meijer Distribution Inc	2024-09-28	HUMAN OTC DRUG LABEL	5