Allergy Relief

Product NDC: 68016-683
11-digit product format: 680160683
Labeler code: 68016
Product ID: 68016-683_2c632d57-d801-46d3-beb6-b7812f177dd7
Type: HUMAN OTC DRUG
Nonproprietary name: Chlorpheniramine maleate
Dosage form: TABLET
Route: ORAL
Labeler: Chain Drug Consortium
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 1992-12-19
Marketing end: 2027-02-28
Substance: CHLORPHENIRAMINE MALEATE
Active strength: 4 mg/1
Pharmacologic classes: Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag: No
Current FDA listing: Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	68016-683	68016-683-82	D	Discontinued by firm		2026-10-16

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 10 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`

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: Allergy Relief

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CHLORPHENIRAMINE MALEATE	4 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
V1Q0O9OJ9Z	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1363309	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
34005c55-3176-4f28-9a3b-7dc6fefd01fe	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
d17a97fa-387f-690e-d2be-0083ab044a03	Product name	3	20170725
0fdb98e2-b951-a1ce-5715-2b187ba500ef	Product name	4	20170718
c6fba691-a132-4ede-95c6-f8c6bd696636	Product name	1	20150902
c0200ab5-4954-454e-9676-30b741b245bd	Product name	1	20150730

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
68016-683-81	Allergy Relief	1 in 1 CARTON	TABLET	1	12
68016-683-81	Allergy Relief	100 in 1 BOTTLE, PLASTIC	TABLET	100	12
68016-683-82	Allergy Relief	2 in 1 CARTON	TABLET	2	12
68016-683-82	Allergy Relief	12 in 1 BLISTER PACK	TABLET	12	12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68016-683-81	EA - Each	68016-683	c7928b99-2c72-4b1d-9a76-b17efa5086a2	1	2022-06-06
68016-683-82	EA - Each	68016-683	20366f41-3fc8-456d-bfd2-29cb29fb7fa2	1	2022-06-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CHLORPHENIRAMINE MALEATE	ACTIVE INGREDIENT	V1Q0O9OJ9Z	ALLERGY RELIEF (CHLORPHENIRAMINE MALEATE) TABLET [CHAIN DRUG CONSORTIUM]	1
CHLORPHENIRAMINE	ACTIVE MOIETY	3U6IO1965U	ALLERGY RELIEF (CHLORPHENIRAMINE MALEATE) TABLET [CHAIN DRUG CONSORTIUM]	1
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	ALLERGY RELIEF (CHLORPHENIRAMINE MALEATE) TABLET [CHAIN DRUG CONSORTIUM]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ALLERGY RELIEF (CHLORPHENIRAMINE MALEATE) TABLET [CHAIN DRUG CONSORTIUM]	1
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	ALLERGY RELIEF (CHLORPHENIRAMINE MALEATE) TABLET [CHAIN DRUG CONSORTIUM]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ALLERGY RELIEF (CHLORPHENIRAMINE MALEATE) TABLET [CHAIN DRUG CONSORTIUM]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	ALLERGY RELIEF (CHLORPHENIRAMINE MALEATE) TABLET [CHAIN DRUG CONSORTIUM]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68016-683	ALLERGY RELIEF (CHLORPHENIRAMINE MALEATE) TABLET [CHAIN DRUG CONSORTIUM]	11	Current NDC, Legacy NDC, 4 package rows	20241027_34005c55-3176-4f28-9a3b-7dc6fefd01fe.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 93 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
VANACOF DM	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	GM Pharmaceuticals, INC	2ed699f2-d004-4fa9-8042-6c85a9ff69b6	2025-11-03	Warnings	Exact identifier application number: M012
Geri Dryl	DIPHENHYDRAMINE HCL	VERITYRX, LLC	42a05f69-0599-5571-e063-6394a90a37d3	2025-11-02	Warnings	Exact identifier application number: M012
M-Dryl	DIPHENHYDRAMINE HYDROCHLORIDE	VERITYRX, LLC	42a0e577-a1b6-2c16-e063-6294a90af8e3	2025-11-02	Warnings	Exact identifier application number: M012
Severe Sinus Congestion and Pain	ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE	Shield Pharmaceuticals Corp	c296efd0-5030-4a26-a9b0-e66423d995dc	2025-10-31	Warnings	Exact identifier application number: M012
Daytime Cold and Flu Max Maximum Strength Softgels	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Topco Associates, LLC	f7ebe482-cb22-4517-8463-3432cf60071d	2025-10-31	Warnings	Exact identifier application number: M012
Nighttime Cold and Flu Max Softgels	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	Topco Associates, LLC	787bff76-0ee2-4e7e-b908-876e4a3e3bfc	2025-10-31	Warnings	Exact identifier application number: M012
Honey Lemon Cough Drops	MENTHOL	Trader Joe's Company	647dadae-f37a-8399-e053-2991aa0aedb3	2025-10-31	Warnings	Exact identifier application number: M012
Family Care Saline	SODIUM CHLORIDE	United Exchange Corp.	06737393-d4ae-3e7b-e063-6394a90ac19f	2025-10-31	Warnings	Exact identifier application number: M012
QUALITY CHOICE Maximum Strength Daytime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Chain Drug Marketing Association, Inc.	40416ff5-06e1-97dd-e063-6394a90a2046	2025-10-30	Warnings	Exact identifier application number: M012
Robitussin Maximum Strength Nighttime Cough DM	DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	Haleon US Holdings LLC	44feee2f-25bc-48d4-8e13-db1d9daaaa90	2025-10-30	Warnings	Exact identifier application number: M012
Robitussin Day and Night Cough Relief DM Max	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, DOXYLAMINE SUCCINATE	Haleon US Holdings LLC	b3d02c91-8f79-4eb4-a378-1072474c572c	2025-10-30	Warnings	Exact identifier application number: M012
ROBITUSSIN MAXIMUM STRENGTH COUGH PLUS CHEST CONGESTION DM	DEXTROMETHORPHAN HBR, GUAIFENESIN	Haleon US Holdings LLC	f1d022dd-c2ca-497f-87d5-9ef3e20e8ea7	2025-10-30	Warnings	Exact identifier application number: M012
Endal	TRIPROLIDINE HCL, DEXTROMETHORPHAN HBR	Poly Pharmaceuticals, Inc.	fc5401e2-ed65-72e7-e053-6294a90a81f3	2025-10-30	Warnings	Exact identifier application number: M012
daytime	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Publix Super Markets Inc	c7cef266-46fc-49ab-a2e7-54fc56298659	2025-10-30	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HYDROCHLORIDE	SAM'S WEST INC	16592ad7-b7cb-0837-e063-6394a90ae059	2025-10-29	Warnings	Exact identifier application number: M012
Maximum Strength Severe Congestion and Cough	DEXTROMETHORPHAN HBR, GUAIFENESIN, AND PHENYLEPHRINE HCL	SAFEWAY	013b94a1-26c7-4371-981a-d1b9d7fd1c98	2025-10-29	Warnings	Exact identifier application number: M012
Better Living	PHENYLEPHRINE HYDROCHLORIDE	BETTER LIVING BRANDS LLC	aea0db7f-e01a-4d8e-9c20-4a5ef4a905d1	2025-10-29	Warnings	Exact identifier application number: M012
AXIM DayTime - Night Time 72 Softgels	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE	VIVUNT PHARMA LLC	de9eb2d5-ba51-4637-e053-2995a90a0451	2025-10-29	Warnings	Exact identifier application number: M012
Dollar General Vapor Steam	CAMPHOR (SYNTHETIC)	DOLGENCORP, LLC	86d0f3ac-1359-c2f9-e053-2a91aa0a35d0	2025-10-29	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HCL	Strategic Sourcing Services LLC	5d628b09-c257-4369-8ddb-47554d83c0d8	2025-10-29	Warnings	Exact identifier application number: M012

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
V1Q0O9OJ9Z	CHLORPHENIRAMINE MALEATE	113-92-8	CHLORPHENIRAMINE MALEATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1363309	chlorpheniramine maleate 4 MG Oral Tablet	PSN	34005c55-3176-4f28-9a3b-7dc6fefd01fe	12
1363309	chlorpheniramine maleate 4 MG Oral Tablet	SCD	34005c55-3176-4f28-9a3b-7dc6fefd01fe	12

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68016-683-81	68016068381	1 BOTTLE, PLASTIC in 1 CARTON (68016-683-81) / 100 TABLET in 1 BOTTLE, PLASTIC		1992-12-19	2027-02-28	No	No	Current
68016-683-82	68016068382	2 BLISTER PACK in 1 CARTON (68016-683-82) > 12 TABLET in 1 BLISTER PACK	2 blister pack	1992-12-19	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Premier Value 44-194 Delisted	Chain Drug Consortium \| LNK International, Inc.	2025-07-19	HUMAN OTC DRUG LABEL	12