Halls

Product NDC: 12546-118
11-digit product format: 125460118
Labeler code: 12546
Product ID: 12546-118_275a09a6-a98d-6f3c-e063-6394a90ab0a6
Type: HUMAN OTC DRUG
Nonproprietary name: Menthol
Dosage form: LOZENGE
Route: ORAL
Labeler: Mondelez Global LLC
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2024-09-24
Substance: MENTHOL
Active strength: 2.5 mg/1
NDC exclude flag: No
Listing certified through: 2026-12-31
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	12546-118	12546-118-30	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 · 9 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…`

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: Halls
Brand name suffix: Green Apple
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
MENTHOL	2.5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
L7T10EIP3A	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
616344	Internal RxNorm lookup
896992	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
1bb8dcb2-c3a8-a64e-e063-6294a90ae4a2	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6	Product name	1	20230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906	Product name	7	20210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cde	Product name	1	20181101
86c45a79-b9f0-4476-a27c-6e10db098497	Product name	1	20180125
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
12546-118-30	HallsGreen Apple	30 in 1 BAG	LOZENGE	30		4
12546-118-80	HallsGreen Apple	80 in 1 BAG	LOZENGE	80		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
12546-118	HALLS GREEN APPLE (MENTHOL) LOZENGE [MONDELEZ GLOBAL LLC]	4	Current NDC, 2 package rows	20241122_1bb8dcb2-c3a8-a64e-e063-6294a90ae4a2.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 30 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Mucinex Fast-Max Severe Congestion and Cough	GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, AND DEXTROMETHORPHAN HYDROBROMIDE	Reckitt Benckiser LLC	1991d5ee-fc90-4070-8965-cd6f4abc45cf	2026-05-13	Warnings	Exact identifier application number: M012
Mucinex Fast-Max Severe Congestion and Cough and Mucinex Nighttime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, AND TRIPROLIDINE HYDROCHLORIDE	Reckitt Benckiser LLC	3b2bb6d0-c5fa-3bfa-e063-6294a90a7afc	2026-05-13	Warnings	Exact identifier application number: M012
Mucinex Fast-Max DM Max and Mucinex Nighttime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND TRIPROLIDINE HYDROCHLORIDE	Reckitt Benckiser LLC	3ba2cc08-acad-79a8-e063-6394a90af17f	2026-05-13	Warnings	Exact identifier application number: M012
Mucinex Fast-Max Cold, Flu and Sore Throat	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Reckitt Benckiser LLC	a3523aa3-9ed1-472d-9986-438440d0a3eb	2026-05-13	Warnings	Exact identifier application number: M012
Mucinex Fast-Max DM Max and Mucinex Nightshift Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND TRIPROLIDINE HYDROCHLORIDE	Reckitt Benckiser LLC	2ed3c844-0532-40d9-beba-738d196de34d	2026-05-13	Warnings	Exact identifier application number: M012
Mucinex Sinus-Max Severe Congestion and Pain	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE	Reckitt Benckiser LLC	1e243dbe-138f-4346-ba22-ceea01e97052	2026-05-13	Warnings	Exact identifier application number: M012
Mucinex Nightshift Severe Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, AND TRIPROLIDINE HYDROCHLORIDE	Reckitt Benckiser LLC	a14bc0d1-9b05-4a21-aaa8-95d4d073b9ed	2026-05-13	Warnings	Exact identifier application number: M012
Mucinex Sinus-Max Severe Congestion Relief	ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Reckitt Benckiser LLC	128f3442-9802-4303-80be-aead09237936	2026-05-13	Warnings	Exact identifier application number: M012
Mucinex Rapid Clear Pain, Headache, and Mucus Congestion and Sinus Max Clear and Cool	OXYMETAZOLINE HYDROCHLORIDE, ACETAMINOPHEN AND GUAIFENESIN	Reckitt Benckiser LLC	33f0d9bb-c67d-92ba-e063-6294a90a9943	2026-05-13	Warnings	Exact identifier application number: M012
Mucinex Sinus-Max Severe Congestion and Pain, Maximum Strength	ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Reckitt Benckiser LLC	2c01962d-74e3-4dfa-b7cb-a91a687711d5	2026-05-13	Warnings	Exact identifier application number: M012
Mucinex Sinus-Max Pressure, Pain and Cough	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Reckitt Benckiser LLC	f5365c6d-9296-41a5-953a-d1008954e67f	2026-05-13	Warnings	Exact identifier application number: M012
Mucinex Sinus-Max Pressure, Pain and Cough	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Reckitt Benckiser LLC	8905706b-b9da-4520-8cf2-87d7c125edf3	2026-05-13	Warnings	Exact identifier application number: M012
MUCINEX Rapid Clear Day Night and Clear and Cool Nasal	ACETAMINOPHEN, GUAIFENESIN, DEXTROMETHORPHAN HYDROBROMIDE, TRIPROLIDINE HYDROCHLORIDE, AND OXYMETAZOLINE HYDROCHLORIDE	Reckitt Benckiser LLC	37dcb0ed-df56-1bec-e063-6394a90a695e	2026-05-13	Warnings	Exact identifier application number: M012
Mucinex Rapid Clear Pain, Headache, and Mucus Congestion and Sinus Max Clear and Cool	OXYMETAZOLINE HYDROCHLORIDE, ACETAMINOPHEN AND GUAIFENESIN	Reckitt Benckiser LLC	373e0d75-8def-4b98-e063-6394a90a5e47	2026-05-13	Warnings	Exact identifier application number: M012
MUCINEX SINUS-MAX SEVERE NASAL CONGESTION RELIEF CLEAR and COOL NASAL	OXYMETAZOLINE HYDROCHLORIDE	Reckitt Benckiser LLC	5a397466-8721-4060-a178-5ebfd7069cc9	2026-05-13	Warnings	Exact identifier application number: M012
Maximum Strength Mucinex Sinus-Max Pressure, Pain and Cough	ACETAMINOPHEN, GUAIFENESIN	Reckitt Benckiser LLC	350764de-7801-b24e-e063-6394a90ab3c3	2026-05-13	Warnings	Exact identifier application number: M012
Cepacol Extra Strength Sore Throat and Cough	BENZOCAINE AND DEXTROMETHORPHAN HYDROBROMIDE	Reckitt Benckiser LLC	c0cc32db-90f0-4106-8538-89821083ece1	2026-05-13	Warnings	Exact identifier application number: M012
Mucinex Nightshift Cold and Flu Maximum Strength	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND TRIPROLIDINE HYDROCHLORIDE	Reckitt Benckiser LLC	316b5569-b66f-f30c-e063-6394a90ae147	2026-05-13	Warnings	Exact identifier application number: M012
Mucinex Nightshift Cold and Flu Maximum Strength	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND TRIPROLIDINE HYDROCHLORIDE	Reckitt Benckiser LLC	d9467ca2-df75-4fa1-92b3-d2101eb54a77	2026-05-13	Warnings	Exact identifier application number: M012
Mucinex Nightshift Severe Cold and Flu Maximum Strength	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, AND TRIPROLIDINE HYDROCHLORIDE	Reckitt Benckiser LLC	12420092-3ef6-464b-9106-2d56cd6ef200	2026-05-13	Warnings	Exact identifier application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
896992	Halls 2.5 MG Oral Lozenge	PSN	1bb8dcb2-c3a8-a64e-e063-6294a90ae4a2	4
616344	menthol 2.5 MG Oral Lozenge	PSN	1bb8dcb2-c3a8-a64e-e063-6294a90ae4a2	4
896992	menthol 2.5 MG Oral Lozenge [Halls]	SBD	1bb8dcb2-c3a8-a64e-e063-6294a90ae4a2	4
616344	menthol 2.5 MG Oral Lozenge	SCD	1bb8dcb2-c3a8-a64e-e063-6294a90ae4a2	4
896992	Halls 2.5 MG Oral Lozenge	SY	1bb8dcb2-c3a8-a64e-e063-6294a90ae4a2	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
12546-118-30	12546011830	30 in 1 BAG					Historical
12546-118-80	12546011880	80 LOZENGE in 1 BAG (12546-118-80)	80 lozenge	2024-09-24	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Halls Green Apple - Mondelez Global LLC \| Mondelez Canada Inc	Mondelez Global LLC \| Mondelez Canada Inc	2024-11-20	HUMAN OTC DRUG LABEL	4