pseudoephedrine hydrochloride

Product NDC: 45802-432
11-digit product format: 458020432
Labeler code: 45802
Product ID: 45802-432_c25dd71c-bfa6-45c6-a4f0-a46919acf185
Type: HUMAN OTC DRUG
Nonproprietary name: Pseudoephedrine HCl
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Padagis Israel Pharmaceuticals Ltd
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2008-10-17
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: pseudoephedrine hydrochloride
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
458594e1-8d99-4de3-8923-2fd8ce2fc406	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	Strength	SPL version
45802-432-62	pseudoephedrine hydrochloride	24 in 1 CARTON	TABLET, FILM COATED	24		7
45802-432-62	pseudoephedrine hydrochloride	1 in 1 BLISTER PACK	TABLET, FILM COATED	1		7

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
45802-432-62	EA - Each	45802-432	48979347-5d83-499a-ab2a-ed912a754428	1	2012-07-24

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
45802-432	PSEUDOEPHEDRINE HYDROCHLORIDE (PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [PADAGIS ISRAEL PHARMACEUTICALS LTD]	7	Current NDC, Legacy NDC, 2 package rows	20240822_458594e1-8d99-4de3-8923-2fd8ce2fc406.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 140 of 177 · 3,534 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Extra Strength TYLENOL Cold Plus Flu Multi-Action Day	ACETAMINOPHEN, PSEUDOEPHEDRINE HYDROCHLORIDE, AND DEXTROMETHORPHAN HYDROBROMIDE	Kenvue Brands LLC	7d3266dc-879a-4d28-b8ea-74d238c3020a	2024-11-07	Warnings	Exact identifier application number: M012
TYLENOL COLD PLUS FLU SEVERE DAY/NIGHT	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Kenvue Brands LLC	2ddb86a8-e34c-4a03-a60a-d3fedaf90608	2024-11-07	Warnings	Exact identifier application number: M012
Tylenol Cold Plus Head Congestion Severe	ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Kenvue Brands LLC	ce43e5c2-fe96-4462-882c-d7479318b33d	2024-11-07	Warnings	Exact identifier application number: M012
TYLENOL SINUS PLUS HEADACHE DAY	ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE	Kenvue Brands LLC	e608d214-cc46-4a24-ac85-1040e36e7403	2024-11-07	Warnings	Exact identifier application number: M012
Childrens TYLENOL COLD PLUS COUGH PLUS SORE THROAT	ACETAMINOPHEN AND DEXTROMETHORPHAN HYDROBROMIDE	Kenvue Brands LLC	e83f7911-22b4-4ffc-8f49-68f6acd2ebf5	2024-11-07	Warnings	Exact identifier application number: M012
Extra Strength TYLENOL Severe Cough Plus Sore Throat Night	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE AND DOXYLAMINE SUCCINATE.	Kenvue Brands LLC	f81d924e-10e9-0e9d-e053-6294a90a2ddf	2024-11-07	Warnings	Exact identifier application number: M012
Childrens TYLENOL COLD Plus FLU	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE	Kenvue Brands LLC	8b516736-86ac-47cb-a0ec-038d4c3a0020	2024-11-07	Warnings	Exact identifier application number: M012
Tylenol Cold plus Flu plus Cough Night	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, AND PHENYLEPHRINE HYDROCHLORIDE	Kenvue Brands LLC	e85e5eb9-3ecf-4784-999e-111e38e306f5	2024-11-07	Warnings	Exact identifier application number: M012
TYLENOL COLD PLUS FLU SEVERE	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Kenvue Brands LLC	ef8a846d-4b29-4fd8-a683-fada04d0a2b9	2024-11-07	Warnings	Exact identifier application number: M012
Childrens TYLENOL COLD Plus FLU	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE	Kenvue Brands LLC	9761c807-75a1-4498-a8c6-1f2b1c9ffde6	2024-11-07	Warnings	Exact identifier application number: M012
TYLENOL Cold Plus Mucus Severe	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Kenvue Brands LLC	24ac94e8-b223-424e-bcd2-9c027c8ff9ed	2024-11-07	Warnings	Exact identifier application number: M012
Primatene	EPHEDRINE HYDROCHLORIDE	Foundation Consumer Brands	2170f081-c03f-47e8-bc63-4052c5e653fa	2024-11-07	Warnings	Exact identifier application number: M012
Rompe Pecho Max Multi Symptoms	ACETAMINOPHEN, DEXTROMETHOPHAN HBR, PHENYLEPHRINE HCL, GUAIFENESIN	EFFICIENT LABORATORIES INC	938e4e47-d2d9-4b0d-bf88-e9f41b501945	2024-11-07	Warnings	Exact identifier application number: M012
topcare sinus nasal	OXYMETAZOLINE HYDROCHLORIDE	Topco Associates LLC	ca1fefed-e9d7-430a-9da4-972b1a6fb786	2024-11-07	Warnings	Exact identifier application number: M012
Leader Daytime Severe Cold and Flu Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Cardinal Health 110, LLC. dba Leader	dd82a389-9ec5-4b3f-a9ea-1a56871ebd17	2024-11-07	Warnings	Exact identifier application number: M012
topcare day time cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Topco Associates LLC	1a8e2e03-e11b-4da1-945b-e2caadea7243	2024-11-07	Warnings	Exact identifier application number: M012
SUDOGEST NASAL DECONGESTANT	PSEUDOEPHEDRINE HCL	A-S Medication Solutions	09feb5f0-c22d-4a1b-97a0-d5767e5f7730	2024-11-07	Warnings	Exact identifier application number: M012
up and up childrens allergy melts	DIPHENHYDRAMINE HCL	Target Corporation	f98d1d54-8e11-4bb1-825a-ab5447d37847	2024-11-07	Warnings	Exact identifier application number: M012
good sense severe day time cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	L. Perrigo Company	44130a1b-63cc-42ac-9590-fdf21a12d164	2024-11-07	Warnings	Exact identifier application number: M012
foster and thrive daytime severe cold and flu relief	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Strategic Sourcing Services LLC	a5ff1134-8985-4585-8e61-a5fd5f60afeb	2024-11-07	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	204849d1-ac4b-4dbe-8769-fcb30291f880	10
1049160	pseudoephedrine hydrochloride 30 MG Oral Tablet	SCD	204849d1-ac4b-4dbe-8769-fcb30291f880	10
1049160	pseudoephedrine HCl 30 MG Oral Tablet	PSN	458594e1-8d99-4de3-8923-2fd8ce2fc406	7
1049160	pseudoephedrine hydrochloride 30 MG Oral Tablet	SCD	458594e1-8d99-4de3-8923-2fd8ce2fc406	7
1049160	pseudoephedrine HCl 30 MG Oral Tablet	PSN	a910320b-0585-40bd-928c-0406346281d0	3
1049160	pseudoephedrine hydrochloride 30 MG Oral Tablet	SCD	a910320b-0585-40bd-928c-0406346281d0	3
1049160	pseudoephedrine HCl 30 MG Oral Tablet	PSN	909dacfa-50d3-4bcf-b2df-5405427cfaad	2
1049160	pseudoephedrine hydrochloride 30 MG Oral Tablet	SCD	909dacfa-50d3-4bcf-b2df-5405427cfaad	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
45802-432-62	45802043262	24 BLISTER PACK in 1 CARTON (45802-432-62) / 1 TABLET, FILM COATED in 1 BLISTER PACK	24 blister pack	2008-10-17	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Pseudoephedrine Hydrochloride 30 mg Drug Facts	Sportpharm LLC	2026-02-06	HUMAN OTC DRUG LABEL	2
Perrigo Pseudoephedrine Hydrochloride 30 mg Drug Facts	Proficient Rx LP	2024-10-01	HUMAN OTC DRUG LABEL	3
Pseudoephedrine Hydrochloride 30 mg Drug Facts	Padagis Israel Pharmaceuticals Ltd	2024-08-16	HUMAN OTC DRUG LABEL	7
Perrigo Pseudoephedrine Hydrochloride 30 mg Drug Facts	A-S Medication Solutions	2023-10-31	HUMAN OTC DRUG LABEL	10