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: 2026-12-31
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: 2026-12-31

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 132 of 178 · 3,550 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Allergy Relief	DIPHENHYDRAMINE HYDROCHLORIDE	TopCo Associates LLC	3ef6d155-b95b-4b30-87a8-8ed811b1520f	2024-12-03	Warnings	Exact identifier application number: M012
Sinus plus Headache	ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE	TOPCARE	a1b2b16d-c767-2945-e053-2995a90a4834	2024-12-03	Warnings	Exact identifier application number: M012
Sinus Congestion and Pain Severe	ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	TopCare	fa9b2748-0474-4a39-a2b8-bb6f0678c1d1	2024-12-03	Warnings	Exact identifier application number: M012
Sinus Pressure plus Pain PE	ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE	TOPCO ASSOCIATES LLC	a9640e09-369c-3c55-e053-2a95a90aebd5	2024-12-03	Warnings	Exact identifier application number: M012
Cold Max	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE	TOPCO ASSOCIATES LLC	ec7e5e2e-23c7-32ae-e053-2995a90a1251	2024-12-03	Warnings	Exact identifier application number: M012
COLD AND FLU SEVERE	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	TOPCARE	cbb179c8-31fb-4a3a-9f23-4024350f8b7f	2024-12-03	Warnings	Exact identifier application number: M012
Allergy Multi Symptom	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE HYDROCHLORIDE	TOPCO ASSOCIATES LLC	a96431a0-b05d-4812-e053-2a95a90a5af6	2024-12-03	Warnings	Exact identifier application number: M012
Cold Max Nighttime	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE	TopCo Associates LLC	aa0d6762-b803-4630-8f74-780b7ea9acff	2024-12-03	Warnings	Exact identifier application number: M012
Cold plus Head Congestion	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE	TOPCO ASSOCIATES LLC	ec7e5e2e-23c5-32ae-e053-2995a90a1251	2024-12-03	Warnings	Exact identifier application number: M012
Cold Plus Head Congestion Day and Night	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE	TopCo Associates LLC	898eb1c7-395a-4845-9d0a-719fc78d86b7	2024-12-03	Warnings	Exact identifier application number: M012
Cold Plus Head Congestion Nighttime	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE	TopCo Associates LLC	7854c1fd-b5fc-477d-a79e-ff006ebf6fe5	2024-12-03	Warnings	Exact identifier application number: M012
Cold and Head Congestion Severe	ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	TopCo Associates LLC	e07d880b-a12a-4e5e-94c0-bd36bcfe738c	2024-12-03	Warnings	Exact identifier application number: M012
Head Congestion plus Mucus PE	ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	TOPCARE	bd0a3679-1f7c-4c41-e053-2995a90a8fcb	2024-12-03	Warnings	Exact identifier application number: M012
Head Congestion plus Flu Severe PE	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	TOPCO ASSOCIATES LLC	bd09e4f3-3211-8c08-e053-2a95a90a73f9	2024-12-03	Warnings	Exact identifier application number: M012
Acetaminophen, Chlorpheniramine Maleate, Phenylephrine HCl	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL	OPMX LLC	b373a3a8-68c4-0187-e053-2995a90aad62	2024-12-03	Warnings	Exact identifier application number: M012
Mucus Relief Cold and Flu All In One	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	TOPCARE	a1b281ec-fd42-963c-e053-2a95a90a4b71	2024-12-03	Warnings	Exact identifier application number: M012
Mucus Relief Cold Flu and Sore Throat	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	TOPCO ASSOCIATES LLC	b3366ad4-5ef4-eb70-e053-2995a90acf33	2024-12-03	Warnings	Exact identifier application number: M012
Meijer Medicated Chest Rub, 3.53 oz. Lavender	MENTHOL, CAMPHOR, EUCALYPTUS OIL	Meijer Distribution	22516f25-b8aa-7511-e063-6394a90a6125	2024-12-03	Warnings	Exact identifier application number: M012
Tenalif Children	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	OPMX LLC	05cd9513-1a42-e990-e063-6294a90a57df	2024-12-03	Warnings	Exact identifier application number: M012
Tenalif Multi Symptom Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	OPMX LLC	05cd94e7-1808-3bb3-e063-6294a90a4140	2024-12-03	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