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 77 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Head Congestion plus Flu Severe PE	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	VALU MERCHANDISERS COMPANY	f6401b58-8cf8-4067-e053-2995a90a68fc	2025-12-11	Warnings	Exact identifier application number: M012
Sinus Relief Pressure, Pain and Cough	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	VALU MERCHANDISERS COMPANY	b1ba37b8-4558-0808-e053-2995a90a9f5e	2025-12-11	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HYDROCHLORIDE	VALU MERCHANDISERS COMPANY	b84f37bc-be37-4f2b-83ee-d7d134184490	2025-12-11	Warnings	Exact identifier application number: M012
Mucus Relief Cold Flu and Sore Throat	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	VALU MERCHANDISERS COMPANY	b1b7c7fc-1068-f486-e053-2a95a90a8e8c	2025-12-11	Warnings	Exact identifier application number: M012
Mucus Relief Cold and Flu All in One	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	VALU MERCHANDISERS COMPANY	b1b9e0da-2c54-8b31-e053-2995a90a690b	2025-12-11	Warnings	Exact identifier application number: M012
Sinus Relief Daytime, Nighttime, Maximum Strength	ACETAMINOPHEN, DIPHENHYDRAMINE HCL, GUAIFENESIN, PHENYLEPHRINE HCL	CVS PHARMACY	f6b3ca40-7638-477f-b800-4c28c40ff0a8	2025-12-11	Warnings	Exact identifier application number: M012
Allergy Relief	ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL	Walgreen Company	0a6e3251-02e0-42c1-bdf3-51c77f88c17f	2025-12-11	Warnings	Exact identifier application number: M012
topcare nite time cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	Topco Associates LLC	516ab016-31f9-4829-8b94-2f968933093c	2025-12-11	Warnings	Exact identifier application number: M012
Sinus PE Congestion	DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL	Walgreen Company	5b9151b7-3e40-4f37-b3e0-4c0fa0115b71	2025-12-10	Warnings	Exact identifier application number: M012
Cough and Cold HBP	CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR	Discount Drug Mart	2344c048-0550-4c31-b54e-a198910c490e	2025-12-10	Warnings	Exact identifier application number: M012
CVS Maximum Strength Cold and Flu Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN ,PHENYLEPHRINE HCL	CVS PHARMACY, INC	cf4eb4c4-68e0-4478-a81c-d3d1e66f5cc5	2025-12-10	Warnings	Exact identifier application number: M012
Tylenol Cold plus Flu Severe, Lil Drug Store	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Lil Drug Store Products, Inc	f395c196-62d7-47ff-b38d-af37adf5980b	2025-12-10	Warnings	Exact identifier application number: M012
Tylenol Sinus Severe, Lil Drug Store	ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Lil Drug Store Products, Inc	88b68447-b016-4d5b-a5e3-c4ebccb14f8c	2025-12-10	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HCL	Family Dollar Services Inc	d956f1b8-91f8-424b-bb6c-704c445b6f4c	2025-12-10	Warnings	Exact identifier application number: M012
good neighbor pharmacy day time cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Amerisource Bergen	e5c1bd96-d27d-49c1-b3b8-eee53a145ef5	2025-12-10	Warnings	Exact identifier application number: M012
NiteTime SEVERE Cold and Flu Relief SOFTGELS	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE	Topco Associates LLC	3ffe67bf-2c66-61e6-e063-6394a90a7f8f	2025-12-10	Warnings	Exact identifier application number: M012
DayTime SEVERE Cold and Flu Relief SOFTGELS	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Topco Associates LLC	3ffe0f43-b92a-f947-e063-6394a90ab72c	2025-12-10	Warnings	Exact identifier application number: M012
MAXIMUM STRENGTH Sinus Relief Day and Night SOFTGELS - 24 ct	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE	Topco Associates LLC	a7285fe0-5a5b-42c4-be47-9a07a2ba75e8	2025-12-10	Warnings	Exact identifier application number: M012
Cold and Flu Relief Nighttime	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	Rite Aid Corporation	f9b8dbe1-7ff9-4320-850c-6e86e98d4393	2025-12-09	Warnings	Exact identifier application number: M012
Severe Nasal	OXYMETAZOLINE HYDROCHLORIDE 0.05%	ALAINA HEALTHCARE PRIVATE LIMITED	27747a10-8d1d-41c2-80b9-45452f3b9abc	2025-12-09	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