Nasal Decongestant

Product NDC: 68016-473
11-digit product format: 680160473
Labeler code: 68016
Product ID: 68016-473_fc83b1ed-bf6b-4bf4-9bcc-365973e7d30d
Type: HUMAN OTC DRUG
Nonproprietary name: Pseudoephedrine HCl
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Chain Drug Consortium
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 1981-08-25
Marketing end: 2027-08-31
Substance: PSEUDOEPHEDRINE HYDROCHLORIDE
Active strength: 30 mg/1
Pharmacologic classes: Adrenergic alpha-Agonists [MoA], alpha-Adrenergic Agonist [EPC]
NDC exclude flag: No
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

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
270e9221-d305-4148-b523-741e02fe733f	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
68016-473-24	Nasal DecongestantMaximum Strength	1 in 1 CARTON	TABLET, FILM COATED	1	14
68016-473-24	Nasal DecongestantMaximum Strength	24 in 1 BLISTER PACK	TABLET, FILM COATED	24	14
68016-473-96	Nasal DecongestantMaximum Strength	4 in 1 CARTON	TABLET, FILM COATED	4	14
68016-473-96	Nasal DecongestantMaximum Strength	24 in 1 BLISTER PACK	TABLET, FILM COATED	24	14

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
PSEUDOEPHEDRINE HYDROCHLORIDE	ACTIVE INGREDIENT	6V9V2RYJ8N	NASAL DECONGESTANT MAXIMUM STRENGTH (PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [CHAIN DRUG CONSORTIUM]	1
PSEUDOEPHEDRINE	ACTIVE MOIETY	7CUC9DDI9F	NASAL DECONGESTANT MAXIMUM STRENGTH (PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [CHAIN DRUG CONSORTIUM]	1
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS	INACTIVE INGREDIENT	L11K75P92J	NASAL DECONGESTANT MAXIMUM STRENGTH (PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [CHAIN DRUG CONSORTIUM]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	NASAL DECONGESTANT MAXIMUM STRENGTH (PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [CHAIN DRUG CONSORTIUM]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	NASAL DECONGESTANT MAXIMUM STRENGTH (PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [CHAIN DRUG CONSORTIUM]	1
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	NASAL DECONGESTANT MAXIMUM STRENGTH (PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [CHAIN DRUG CONSORTIUM]	1
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	NASAL DECONGESTANT MAXIMUM STRENGTH (PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [CHAIN DRUG CONSORTIUM]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	NASAL DECONGESTANT MAXIMUM STRENGTH (PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [CHAIN DRUG CONSORTIUM]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	NASAL DECONGESTANT MAXIMUM STRENGTH (PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [CHAIN DRUG CONSORTIUM]	1
POLYDEXTROSE	INACTIVE INGREDIENT	VH2XOU12IE	NASAL DECONGESTANT MAXIMUM STRENGTH (PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [CHAIN DRUG CONSORTIUM]	1
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	NASAL DECONGESTANT MAXIMUM STRENGTH (PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [CHAIN DRUG CONSORTIUM]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	NASAL DECONGESTANT MAXIMUM STRENGTH (PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [CHAIN DRUG CONSORTIUM]	1
TRIACETIN	INACTIVE INGREDIENT	XHX3C3X673	NASAL DECONGESTANT MAXIMUM STRENGTH (PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [CHAIN DRUG CONSORTIUM]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68016-473	NASAL DECONGESTANT MAXIMUM STRENGTH (PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [CHAIN DRUG CONSORTIUM]	13	Current NDC, Legacy NDC, 4 package rows	20250309_270e9221-d305-4148-b523-741e02fe733f.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 136 of 177 · 3,534 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
nasal	OXYMETAZOLINE HYDROCHLORIDE	Meijer Distribution Inc	ec8db98f-4fd1-4644-b76f-ff04f72e87f4	2024-11-13	Warnings	Exact identifier application number: M012
dg health tussin	DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	Dolgencorp, LLC	6f9b8267-1e0b-430b-8e44-06408ae82ea4	2024-11-13	Warnings	Exact identifier application number: M012
Walgreens Effervescent Cold Relief Plus	ASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATE	Walgreens	b60e2cf9-11ec-469e-e053-2a95a90a712a	2024-11-13	Warnings	Exact identifier application number: M012
Kroger Effervescent Cold Relief	ASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATE	Kroger Company	69333774-3cf4-384d-e053-2a91aa0a48b3	2024-11-13	Warnings	Exact identifier application number: M012
Effervescent Orange Cold Relief	ASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATE	H. E. Butt Grocery Company	6403fe3d-d82b-f4d5-e053-2991aa0ac7d6	2024-11-13	Warnings	Exact identifier application number: M012
Effervescent Cold Relief	ASPIRIN, CHLORPHENIRAMINE MALEATE, PHYLEPHRINE BITARTRATE	Topco Associates LLC	a2929bcb-fa81-4f15-b087-a9996b5e7d1f	2024-11-13	Warnings	Exact identifier application number: M012
Equate Effervescent Cold Relief	ASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATE	Walmart	6271bb48-74b2-eb57-e053-2991aa0afd1b	2024-11-13	Warnings	Exact identifier application number: M012
Equaline Effervescent Cold Relief	ASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATE	United Natural Foods, Inc. dba UNFI	6bf341e0-94b1-08ff-e053-2991aa0af634	2024-11-13	Warnings	Exact identifier application number: M012
Good Sense Effervescent Cold Relief	ASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATE	Good Sense	cd25e250-bb8b-7e83-e053-2a95a90a2639	2024-11-13	Warnings	Exact identifier application number: M012
Top Value Effervescent Cold Relief	ASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATE	Tower Laboratories Ltd	440a00b1-7960-0cc4-e054-00144ff8d46c	2024-11-13	Warnings	Exact identifier application number: M012
Top Value Effervescent Cold Relief - Orange	ASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATE	Tower Laboratories Ltd.	c6f207e8-bc0d-853a-e053-2a95a90ac623	2024-11-13	Warnings	Exact identifier application number: M012
Effervescent Orange Cold Relief	ASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATE	DOLGENCORP, LLC	7fad8e65-34fe-5313-e053-2a91aa0a56f4	2024-11-13	Warnings	Exact identifier application number: M012
Dollar General Effervescent Cold Relief	ASPIRIN, CHLORPHENIRAMINE MALEATE, PHYLEPHRINE BITARTRATE	DOLGENCORP, LLC	7face5c7-f5c7-7eee-e053-2991aa0ab064	2024-11-13	Warnings	Exact identifier application number: M012
Quality Choice Effervescent Cold Relief Plus	ASPIRIN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE BITARTRATE	Chain Drug Marketing Association	90622927-9682-4eb0-8c7f-894230b3dda4	2024-11-13	Warnings	Exact identifier application number: M012
Quality Choice Effervescent Cold Relief - Orange	ASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATE	Chain Drug Marketing Association	9f7d76f0-4f1c-a1c7-e053-2a95a90a3dca	2024-11-13	Warnings	Exact identifier application number: M012
WinCo Foods Effervescent Cold Relief	ASPIRIN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE BITARTRATE	WinCo Foods, LLC	d443a030-d3d6-40e0-8fe0-329de6bc494f	2024-11-13	Warnings	Exact identifier application number: M012
careone tussin dm	DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	American Sales Company	954fe703-9a10-4354-8b71-4d98a22a0b9f	2024-11-13	Warnings	Exact identifier application number: M012
NASAL DECONGESTANT PE	PHENYLEPHRINE HCL	A-S Medication Solutions	9d030767-dfd6-48b4-9b17-4e20c23915f3	2024-11-13	Warnings	Exact identifier application number: M012
Childrens SUDAFED PE Cold plus Cough	DEXTROMETHORPHAN HYDROBROMIDE AND PHENYLEPHRINE HYDROCHLORIDE	Kenvue Brands LLC	20e45243-3989-413a-bcf1-49d754ff2e44	2024-11-12	Warnings	Exact identifier application number: M012
Tukol Cough And Cold Honey Flavor	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Genomma Lab USA	a4b333dc-58da-45db-87b6-6fcb8fb542b8	2024-11-12	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	270e9221-d305-4148-b523-741e02fe733f	14
1049160	pseudoephedrine hydrochloride 30 MG Oral Tablet	SCD	270e9221-d305-4148-b523-741e02fe733f	14

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68016-473-24	68016047324	1 BLISTER PACK in 1 CARTON (68016-473-24) / 24 TABLET, FILM COATED in 1 BLISTER PACK	1 blister pack	1981-08-25	2027-08-31	No	No	Current
68016-473-96	68016047396	4 BLISTER PACK in 1 CARTON (68016-473-96) / 24 TABLET, FILM COATED in 1 BLISTER PACK	4 blister pack	1981-08-25	2027-08-31	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Premier Value 44-112-Delisted	Chain Drug Consortium \| LNK International, Inc.	2025-07-18	HUMAN OTC DRUG LABEL	14