Allergy Relief

Product NDC: 70000-0160
11-digit product format: 700000160
Labeler code: 70000
Product ID: 70000-0160_cad6c859-0a91-4d1a-be53-1b702ec8efce
Type: HUMAN OTC DRUG
Nonproprietary name: Chlorpheniramine maleate
Dosage form: TABLET
Route: ORAL
Labeler: Cardinal Health 110, LLC. DBA Leader
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 1992-12-19
Substance: CHLORPHENIRAMINE MALEATE
Active strength: 4 mg/1
Pharmacologic classes: Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag: No
Listing certified through: 2027-12-31
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	70000-0160	70000-0160-1	D	Discontinued by firm		2026-10-23

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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	70000-0160	70000-0160-1	D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	70000-0160	70000-0160-1	D	Discontinued by firm		excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`

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
Brand name suffix: 4 Hour
Listing expiration: 2027-12-31

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
aaecfda5-1a50-4d8a-9909-7153c1a22bda	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
70000-0160-1	Allergy Relief4 Hour	2 in 1 CARTON	TABLET	2	15
70000-0160-1	Allergy Relief4 Hour	12 in 1 BLISTER PACK	TABLET	12	15
70000-0160-2	Allergy Relief4 Hour	1 in 1 CARTON	TABLET	1	15
70000-0160-2	Allergy Relief4 Hour	100 in 1 BOTTLE	TABLET	100	15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
70000-0160-1	EA - Each	70000-0160	13e95c3a-e091-44ed-8a21-3b7a4b278816	1	2018-12-13
70000-0160-2	EA - Each	70000-0160	625564fe-e437-4949-b458-c6ddb9e5e05b	1	2018-12-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70000-0160	ALLERGY RELIEF 4 HOUR (CHLORPHENIRAMINE MALEATE) TABLET [CARDINAL HEALTH 110, LLC. DBA LEADER]	13	Current NDC, Legacy NDC, 4 package rows	20240702_aaecfda5-1a50-4d8a-9909-7153c1a22bda.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 80 of 178 · 3,550 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Basic Care Cherry Cough Drops	MENTHOL	Amazon.com	c0588221-0c84-66d8-e053-2995a90a874f	2025-12-05	Warnings	Exact identifier application number: M012
Basic Care Honey Lemon Cough Drops	MENTHOL	Amazon.com	c0937b13-f679-a764-e053-2a95a90abf89	2025-12-05	Warnings	Exact identifier application number: M012
Basic Care SF Menthol Cough Drops	MENTHOL	Amazon.com	c0946295-7cf0-1bd8-e053-2a95a90af5af	2025-12-05	Warnings	Exact identifier application number: M012
Basic Care SF Honey Lemon Cough Drops	MENTHOL	Amazon.com	cf82fb0b-1b4d-def1-e053-2995a90a6fd9	2025-12-05	Warnings	Exact identifier application number: M012
G-DOLOGEN	ACETAMINOPHEN, DEXBROMPHENIRAMINE MALEATE	Kramer Novis	7a4e1d64-2510-405f-a1dc-e02a803b6fbd	2025-12-05	Warnings	Exact identifier application number: M012
Quality Choice Severe Cold and Cough Nighttime	ACETAMINOPHEN, DIPHENHYDRAMINE, PHENYLEPHRINE	Chain Drug Manufacturing Assn	ce658dd5-b683-436e-b16b-0c06f6f87fd9	2025-12-04	Warnings	Exact identifier application number: M012
Quality Choice Maximum Strength	OXYMETAZOLINE HYDROCHLORIDE	CHAIN DRUG MARKETING ASSOCIATION	a87ba15f-b5a9-4983-a721-ca7f705aea86	2025-12-04	Warnings	Exact identifier application number: M012
Quality Choice	PHENYLEPHRINE HYDROCHLORIDE	CHAIN DRUG MARKETING ASSOCIATION	a12e2e66-d2f3-47a6-a915-a309ae828d27	2025-12-04	Warnings	Exact identifier application number: M012
Childrens Mucus Relief Chest Congestion	GUAIFENESIN	Chain Drug Manufacturing Assn	034d39c0-9aad-4dff-a158-a041b9f0504f	2025-12-04	Warnings	Exact identifier application number: M012
Quality Choice	OXYMETAZOLINE HYDROCHLORIDE	CHAIN DRUG MARKETING ASSOCIATION	d01b8fb6-1ddf-4901-bda6-ae608e94a6a4	2025-12-04	Warnings	Exact identifier application number: M012
Childrens Mucus and Cough Relief	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	Chain Drug Manufacturing Assn	06822a28-3f82-471d-8db5-c5981b263a03	2025-12-04	Warnings	Exact identifier application number: M012
QUALITY CHOICE	PHENYLEPHRINE HYDROCHLORIDE	CHAIN DRUG MARKETING ASSOCIATION	14596551-dd82-46b3-8eb8-e69efaea105b	2025-12-04	Warnings	Exact identifier application number: M012
Daytime Cold and Flu Lil Drug Store Products	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE	Lil' Drug Store Products, Inc	fd5c20ed-5520-4db0-bfd4-995f043af2a4	2025-12-04	Warnings	Exact identifier application number: M012
Afrin Original	OXYMETAZOLINE HYDROCHLORIDE	Bayer HealthCare LLC.	89c165ba-3ad5-49b5-a5bb-423dc8e15bad	2025-12-04	Warnings	Exact identifier application number: M012
Alka-Seltzer Plus Severe Cold Powerfast Fizz Night	ASPIRIN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE BITARTRATE	Bayer HealthCare LLC.	a2b30c27-b836-f09f-e053-2995a90ac383	2025-12-04	Warnings	Exact identifier application number: M012
Alka-Seltzer Plus Severe Cold PowerFast Fizz	ASPIRIN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATE, DOXYLAMINE SUCCINATE	Bayer HealthCare LLC.	a37c9d9d-52db-23ff-e053-2995a90a8f76	2025-12-04	Warnings	Exact identifier application number: M012
Alka-Seltzer Plus Severe Cold and Cough PowerFast Fizz	ASPIRIN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATE	Bayer Healthcare LLC.	dd7d8a8c-0f91-5ef1-e053-2a95a90a3c6a	2025-12-04	Warnings	Exact identifier application number: M012
Alka-Seltzer Plus Cough, Mucus and Congestion Day and Night Powermax	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Bayer HealthCare LLC.	a68df74d-dd26-3ae9-e053-2995a90a08d6	2025-12-04	Warnings	Exact identifier application number: M012
Circle K Daytime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE	Lil' Drug Store Products, Inc.	55662ada-677e-4048-9529-5bca44076316	2025-12-04	Warnings	Exact identifier application number: M012
Alka-Seltzer Plus Maximum Strength Day and Night Cold and Flu	DEXTROMETHORPHAN HYDROBROMIDE, ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE	Bayer HealthCare LLC.	b13d5132-cb91-3cf6-e053-2a95a90aa47c	2025-12-04	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	aaecfda5-1a50-4d8a-9909-7153c1a22bda	15
1363309	chlorpheniramine maleate 4 MG Oral Tablet	SCD	aaecfda5-1a50-4d8a-9909-7153c1a22bda	15

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
70000-0160-1	70000016001	2 BLISTER PACK in 1 CARTON (70000-0160-1) > 12 TABLET in 1 BLISTER PACK	2 blister pack	1992-12-19	0000-00-00	No	No	Current
70000-0160-2	70000016002	1 BOTTLE in 1 CARTON (70000-0160-2) / 100 TABLET in 1 BOTTLE	1 bottle	1992-12-19	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Leader 44-194	Cardinal Health 110, LLC. DBA Leader \| LNK International, Inc.	2026-07-08	HUMAN OTC DRUG LABEL	16