ClorRelief

Product NDC: 82643-002
11-digit product format: 826430002
Labeler code: 82643
Product ID: 82643-002_526f9c82-d393-f544-e063-6394a90a29d9
Type: HUMAN OTC DRUG
Nonproprietary name: Chlorpheniramine Maleate
Dosage form: AEROSOL, SPRAY
Route: ORAL
Labeler: FERRER MEDICAL INNOVATIONS LLC
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2023-04-21
Substance: CHLORPHENIRAMINE MALEATE
Active strength: 5 mg/mL
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

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 · 18 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	82643-002-15	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	82643-002-15	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	82643-002-15	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	82643-002-15	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	82643-002-15	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	82643-002-15	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	82643-002-15	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	82643-002-15	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	82643-002-15	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`

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: ClorRelief
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CHLORPHENIRAMINE MALEATE	5 mg/mL

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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2610305	Internal RxNorm lookup
2610310	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
db729011-f72f-5911-e053-2a95a90a68bf	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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
82643-002-15	2025-01-30	C162847	48780-1	2cef2736-720d-d83d-e063-dadaa90ab31f	ClorRelief (Chlorpheniramine Maleate 0.5%) Antihistamine Oral Spray

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
82643-002-15	ClorRelief	15 mL in 1 BOTTLE, WITH APPLICATOR	AEROSOL, SPRAY	15		4
82643-002-15	ClorRelief	1 in 1 CARTON	AEROSOL, SPRAY	1		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
82643-002	CLORRELIEF (CHLORPHENIRAMINE MALEATE) AEROSOL, SPRAY [FERRER MEDICAL INNOVATIONS LLC]	3	Current NDC, Legacy NDC, 2 package rows	20230422_db729011-f72f-5911-e053-2a95a90a68bf.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 16 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Allergy Relief	DIPHENHYDRAMINE HCL	WinCo Foods, LLC	2cbf27b6-217c-46d8-89c9-e46f3668f002	2026-07-17	Warnings	Exact identifier application number: M012
Best Choice	OXYMETAZOLINE HYDROCHLORIDE	BEST CHOICE (VALU MERCHANDISERS COMPANY)	d86d53cd-75ce-4c40-83cb-ada9b77a76f6	2026-07-17	Warnings	Exact identifier application number: M012
LEADER Multi Symptom Flu Relief Daytime Max Strength	ACETAMINOPHEN, DEXTROMETHORPHAN HBR	CARDINAL HEALTH 110, LLC. DBA LEADER	2212cf9e-6944-4922-b5b5-1373cf10b2e1	2026-07-16	Warnings	Exact identifier application number: M012
Cold and Flu HBP	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE	CVS PHARMACY	06756130-1608-4ae6-9772-95a4549853a1	2026-07-16	Warnings	Exact identifier application number: M012
Medicated Chest Rub	CAMPHOR, EUCALYPTUS OIL, MENTHOL	Old East Main Co.	7855033e-6a12-4cd8-b0a2-c5d69018d117	2026-07-16	Warnings, Adverse reactions	Exact identifier application number: M012
Oxymetazoline Hydrochloride 12-Hour	OXYMETAZOLINE HYDROCHLORIDE	Sun Pharmaceutical Industries, Inc.	34a79f8b-32b7-48db-a895-c942cc795292	2026-07-16	Warnings	Exact identifier application number: M012
LoHist D	CHLORPHENIRAMINE MALEATE / PSEUDOEPHEDRINE HCL	Larken Laboratories, Inc.	93c9ad4f-3376-48c2-8276-0375663acd01	2026-07-16	Warnings	Exact identifier application number: M012
Sanatos	MENTHOL	Pharmadel LLC	522e1e7f-98ed-c475-e063-6294a90a622c	2026-07-16	Warnings	Exact identifier application number: M012
LEADER MS Flu Relief Nighttime	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE AND DEXTROMETHOPHAN HBR	CARDINAL HEALTH 110, LLC. DBA LEADER	9db7d4e2-f7c1-41a7-8e1c-ef8d3512259d	2026-07-16	Warnings	Exact identifier application number: M012
NIGHTTIME COLD AND FLU	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	Amazon.com Services LLC	1bf4cd96-5800-434d-a0dc-e84c759ebb33	2026-07-16	Warnings	Exact identifier application number: M012
Mucus Relief Cough Childrens	DEXTROMETHORPHAN HBR, GUAIFENSIN	Walgreens	2ace231a-94c4-479d-bb26-454bd07b207b	2026-07-16	Warnings	Exact identifier application number: M012
LEADER No Drip	ALLERGY SINUS NASAL MIST	CARDINAL HEALTH 110, LLC. DBA LEADER	e7b2c1c1-6250-4af3-b131-22aced2b23d5	2026-07-16	Warnings	Exact identifier application number: M012
Mucus Relief DM Cough	DEXTROMETHORPHAN HBR, GUAIFENESIN	Amerisource Bergen	639a59b7-ccff-485e-a232-38b680827229	2026-07-16	Warnings	Exact identifier application number: M012
Equate Nighttime Vapor Ice Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	WALMART INC.	30470a01-4d42-44c6-a017-d68bb74cdef7	2026-07-15	Warnings	Exact identifier application number: M012
Quality Choice Effervescent Cold Relief - Plus	ASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATE	Chain Drug Marketing Association	1f93fe6d-ee21-e323-e063-6394a90a61bf	2026-07-15	Warnings	Exact identifier application number: M012
Pentrexcilina Daytime	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL	OPMX LLC	b7b3c15a-bb28-5c25-e053-2a95a90ad3b1	2026-07-15	Warnings	Exact identifier application number: M012
Quality Choice Effervescent Cold Relief - Orange	ASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATE	Chain Drug Marketing Association	1f93c815-63c7-bfe0-e063-6394a90ab4a5	2026-07-15	Warnings	Exact identifier application number: M012
Nighttime Severe Cold and Flu Maximum Strength mini softgels	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	Shield Pharmaceuticals Corp	5fa848ef-35ee-4e05-8ff2-781d034cf6ac	2026-07-14	Warnings	Exact identifier application number: M012
Cough and Cold HBP	CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR	Cardinal Health 110, LLC. DBA Leader	0fad61d8-4393-47ec-9ff6-7df5be761f5b	2026-07-14	Warnings	Exact identifier application number: M012
Sinus and Allergy Relief PE	CHLORPHENIRAMINE MALEATE AND PHENYLEPHRINE HCL	Rite Aid Corporation	211c4273-3b2c-4169-b9c6-7a87903e77cd	2026-07-13	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
2610305	chlorpheniramine maleate 0.5 % Mucosal Spray	PSN	db729011-f72f-5911-e053-2a95a90a68bf	4
2610310	ClorRelief 0.5 % Mucosal Spray	PSN	db729011-f72f-5911-e053-2a95a90a68bf	4
2610310	chlorpheniramine maleate 5 MG/ML Mucosal Spray [Clorrelief]	SBD	db729011-f72f-5911-e053-2a95a90a68bf	4
2610305	chlorpheniramine maleate 5 MG/ML Mucosal Spray	SCD	db729011-f72f-5911-e053-2a95a90a68bf	4
2610305	chlorpheniramine maleate 0.5 % Mucosal Spray	SY	db729011-f72f-5911-e053-2a95a90a68bf	4
2610310	ClorRelief 0.5 % Mucosal Spray	SY	db729011-f72f-5911-e053-2a95a90a68bf	4
2610310	Clorrelief 5 MG/ML Mucosal Spray	SY	db729011-f72f-5911-e053-2a95a90a68bf	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
82643-002-01	82643000201	120 mL in 1 BOTTLE, SPRAY (82643-002-01)	120 ml	2022-09-01	0000-00-00	No	No	Current
82643-002-15	82643000215	1 BOTTLE, WITH APPLICATOR in 1 CARTON (82643-002-15) / 15 mL in 1 BOTTLE, WITH APPLICATOR		2023-04-24		No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
ClorRelief (Chlorpheniramine Maleate 0.5%) Antihistamine Oral Spray	FERRER MEDICAL INNOVATIONS LLC \| Xlear Inc.	2026-05-22	HUMAN OTC DRUG LABEL	4