Aller-chlor

Product NDC: 0536-1006
11-digit product format: 005361006
Labeler code: 0536
Product ID: 0536-1006_7457e524-40ab-432f-a48a-b32eb2c0a93f
Type: HUMAN OTC DRUG
Nonproprietary name: Chlorpheniramine Maleate
Dosage form: TABLET
Route: ORAL
Labeler: Rugby Laboratories
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	0536-1006	0536-1006-35	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 · 12 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…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

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: Aller-chlor
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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1363309	Internal RxNorm lookup
1363315	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
04ca3806-72be-47d4-9fea-5b0dee087683	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
0536-1006-01	Aller-chlor	100 in 1 BOTTLE, PLASTIC	TABLET	100	16
0536-1006-01	Aller-chlor	1 in 1 CARTON	TABLET	1	16
0536-1006-10	Aller-chlor	1000 in 1 BOTTLE, PLASTIC	TABLET	1000	16
0536-1006-35	Aller-chlor	12 in 1 BLISTER PACK	TABLET	12	16
0536-1006-35	Aller-chlor	2 in 1 CARTON	TABLET	2	16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0536-1006-01	EA - Each	0536-1006	270e3d12-6807-4d73-a4ac-8095b9e4ddd1	1	2015-01-05
0536-1006-10	EA - Each	0536-1006	408f78fc-0a2b-4ee6-bf90-2376920c8427	1	2014-10-03
0536-1006-35	EA - Each	0536-1006	12500282-7eed-43ac-ae9d-c106fee79878	1	2014-06-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CHLORPHENIRAMINE MALEATE	ACTIVE INGREDIENT	V1Q0O9OJ9Z	ALLER-CHLOR (CHLORPHENIRAMINE MALEATE) TABLET [RUGBY LABORATORIES]	4
CHLORPHENIRAMINE	ACTIVE MOIETY	3U6IO1965U	ALLER-CHLOR (CHLORPHENIRAMINE MALEATE) TABLET [RUGBY LABORATORIES]	4
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	ALLER-CHLOR (CHLORPHENIRAMINE MALEATE) TABLET [RUGBY LABORATORIES]	4
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ALLER-CHLOR (CHLORPHENIRAMINE MALEATE) TABLET [RUGBY LABORATORIES]	4
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	ALLER-CHLOR (CHLORPHENIRAMINE MALEATE) TABLET [RUGBY LABORATORIES]	4
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ALLER-CHLOR (CHLORPHENIRAMINE MALEATE) TABLET [RUGBY LABORATORIES]	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0536-1006	ALLER-CHLOR (CHLORPHENIRAMINE MALEATE) TABLET [RUGBY LABORATORIES]	15	Current NDC, Legacy NDC, 5 package rows	20250512_04ca3806-72be-47d4-9fea-5b0dee087683.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 29 of 178 · 3,550 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Antihistamine	DIPHENHYDRAMINE HCL	Gendose Pharmaceuticals, LLC	847cdee8-410f-4ff3-9245-976ed6f4c776	2026-05-15	Warnings	Exact identifier application number: M012
Antihistamine	DIPHENHYDRAMINE HCL	Gendose Pharmaceuticals, LLC	d3b2f300-d919-44cd-ab71-b74b5bdfd977	2026-05-15	Warnings	Exact identifier application number: M012
ONESSIP DAY TIME KIDS COLD AND COUGH PLUS FEVER	ACETAMINOPHEN 325 MG AND DEXTROMETHORPHAN HBR 10 MG ORAL LIQUID DAY TIME KIDS	MEDWISE LIFESCIENCES INC.	51d52ce4-98c4-2b9b-e063-6294a90ade44	2026-05-15	Warnings	Exact identifier application number: M012
Curewell Tussin DM	DEXTROMETHORPHAN, GUAIFENESIN	RMT HEALTH LLC	4fe9ad93-cdc4-b4df-e063-6294a90a90ae	2026-05-15	Warnings	Exact identifier application number: M012
CounterAct Cough Drops Orchard Cherry	MENTHOL	Melaleuca, Inc.	6049842c-d763-4a91-a225-976ed74e1693	2026-05-15	Warnings	Exact identifier application number: M012
CounterAct Cough Drops Honey Lemon	MENTHOL	Melaleuca, Inc.	84ac3489-9d64-401f-ab78-715af4de5440	2026-05-15	Warnings	Exact identifier application number: M012
ALKA SELTZER COLD Cold Flu and Congestion Maximum Strength Day Night Fast Gels	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE	Bayer HealthCare LLC.	51e03b5b-b05a-07c1-e063-6394a90ab201	2026-05-15	Warnings	Exact identifier application number: M012
Sinus Congestion and Pain Relief Non-Drowsy/Daytime	ACETAMINOPHEN, GUAIFENESIN AND PHENYLEPHRINE HCL	Rite Aid Corporation	38d73a1e-ac78-4f67-9291-bb48ab80306e	2026-05-15	Warnings	Exact identifier application number: M012
Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR	WALMART INC.	071615ba-f50a-4d2a-a358-43140bccce72	2026-05-14	Warnings	Exact identifier application number: M012
Severe Cold and Flu Nighttime Daytime	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	HyVee Inc	d4bcfabb-a054-4f53-8dc9-d361a03558b8	2026-05-14	Warnings	Exact identifier application number: M012
Cough and Chest Congestion DM Adult	DEXTROMETHORPHAN HBR, GUAIFENESIN	CVS Pharmacy	4444c05a-eba6-4633-b86f-34f455699fa9	2026-05-14	Warnings	Exact identifier application number: M012
Topcare Day Time Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Topco Associates LLC	a88e5b8e-e6dd-4a1c-9628-5861d3205bdb	2026-05-14	Warnings	Exact identifier application number: M012
equate daytime cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Wal-Mart Stores Inc	69b24c67-cf4b-46d7-a44b-d1917cc876b1	2026-05-14	Warnings	Exact identifier application number: M012
GILTUSS DIABETIC EX	GILTUSS DIABETIC EX	Gil Pharmaceutical Corp	ab7915e7-323a-4fe1-887a-a3bd3f0aac98	2026-05-13	Warnings	Exact identifier application number: M012
Giltuss EX Maximum Strength Expectorant	GILTUSS EX MAXIMUM STRENGTH EXPECTORANT	Gil Pharmaceutical Corp	950db1ca-6936-47f8-a112-e3594d4c922c	2026-05-13	Warnings	Exact identifier application number: M012
Giltuss EX Expectorant	GILTUSS EX EXPECTORANT	Gil Pharmaceutical Corp	3b363fb9-c4d3-446f-927c-f705ffc715b5	2026-05-13	Warnings	Exact identifier application number: M012
Giltuss HBP EX Expectorant	GILTUSS HBP EX EXPECTORANT	Gil Pharmaceutical Corp	31bd6356-27cf-4188-8fd5-9cd9392021ca	2026-05-13	Warnings	Exact identifier application number: M012
Halls Honey Lemon	MENTHOL	Mondelez Global LLC	aec46410-ffb1-4db4-b232-82110c562f69	2026-05-13	Warnings	Exact identifier application number: M012
Mucinex Fast-Max Chest Congestion Honey and Berry Flavor	GUAIFENESIN	Reckitt Benckiser LLC	8ec74cf2-88f5-40be-87e2-b756ab841754	2026-05-13	Warnings	Exact identifier application number: M012
Mucinex Fast-Max Cold and Flu	ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, AND DEXTROMETHORPHAN HYDROBROMIDE	Reckitt Benckiser LLC	c16253d3-3824-458c-8840-e3a2fbe7682c	2026-05-13	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
1363309	chlorpheniramine maleate 4 MG Oral Tablet	PSN	7a3452a2-930f-48b1-8c59-dbceb10b9c78	18
1363309	chlorpheniramine maleate 4 MG Oral Tablet	SCD	7a3452a2-930f-48b1-8c59-dbceb10b9c78	18
1363315	Aller-Chlor 4 MG Oral Tablet	PSN	04ca3806-72be-47d4-9fea-5b0dee087683	16
1363309	chlorpheniramine maleate 4 MG Oral Tablet	PSN	04ca3806-72be-47d4-9fea-5b0dee087683	16
1363315	chlorpheniramine maleate 4 MG Oral Tablet [Aller-Chlor]	SBD	04ca3806-72be-47d4-9fea-5b0dee087683	16
1363309	chlorpheniramine maleate 4 MG Oral Tablet	SCD	04ca3806-72be-47d4-9fea-5b0dee087683	16
1363315	Aller-Chlor 4 MG Oral Tablet	SY	04ca3806-72be-47d4-9fea-5b0dee087683	16

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0536-1006-01	00536100601	1 BOTTLE, PLASTIC in 1 CARTON (0536-1006-01) / 100 TABLET in 1 BOTTLE, PLASTIC		1992-12-19	2027-01-31	No	No	Current
0536-1006-10	00536100610	1000 TABLET in 1 BOTTLE, PLASTIC (0536-1006-10)	1000 tablet	1992-12-19	0000-00-00	No	No	Current
0536-1006-35	00536100635	12 in 1 BLISTER PACK						Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Chlorpheniramine Maleate	PD-Rx Pharmaceuticals, Inc.	2026-08-10	HUMAN OTC DRUG LABEL	19
Rugby 44-194	Rugby Laboratories \| LNK International, Inc.	2026-07-08	HUMAN OTC DRUG LABEL	17
Rugby 44-194	A-S Medication Solutions	2023-02-04	HUMAN OTC DRUG LABEL	14