Halls
- Product NDC
- 12546-110
- 11-digit product format
- 125460110
- Labeler code
- 12546
- Product ID
- 12546-110_51b2efc4-6f46-16dc-e063-6294a90a509e
- 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
- 2019-03-24
- Substance
- MENTHOL
- Active strength
- 7.5 mg/1
- 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.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded package | package | 12546-110 | 12546-110-02 | D | Discontinued by firm | 2026-10-16 | |
| excluded package | package | 12546-110 | 12546-110-03 | D | Discontinued by firm | 2026-10-16 | |
| excluded package | package | 12546-110 | 12546-110-04 | D | Discontinued by firm | 2026-10-16 | |
| excluded package | package | 12546-110 | 12546-110-16 | D | Discontinued by firm | 2026-10-16 | |
| excluded package | package | 12546-110 | 12546-110-18 | D | Discontinued by firm | 2026-10-16 | |
| excluded package | package | 12546-110 | 12546-110-24 | D | Discontinued by firm | 2026-10-16 | |
| excluded package | package | 12546-110 | 12546-110-40 | D | Discontinued by firm | 2026-10-16 | |
| excluded package | package | 12546-110 | 12546-110-96 | D | Discontinued by firm | 2026-10-16 | |
| excluded package | package | 12546-110 | 12546-110-99 | 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.
| Captured / source date | Package NDC | Snapshot | Source SHA-256 |
|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | 12546-110-16 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | 12546-110-40 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | 12546-110-02 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | 12546-110-18 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | 12546-110-96 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | 12546-110-99 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | 12546-110-24 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | 12546-110-03 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | 12546-110-04 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | 12546-110-16 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | 12546-110-40 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | 12546-110-02 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | 12546-110-18 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | 12546-110-96 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | 12546-110-99 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | 12546-110-24 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | 12546-110-03 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | 12546-110-04 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 12546-110-40 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 12546-110-03 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 12546-110-16 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 12546-110-24 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 12546-110-99 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 12546-110-96 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 12546-110-02 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 12546-110-18 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 12546-110-04 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | 12546-110-40 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | 12546-110-03 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | 12546-110-16 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | 12546-110-24 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | 12546-110-99 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | 12546-110-96 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | 12546-110-02 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | 12546-110-18 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | 12546-110-04 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | 12546-110-40 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | 12546-110-03 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | 12546-110-16 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | 12546-110-24 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | 12546-110-99 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | 12546-110-96 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | 12546-110-02 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | 12546-110-18 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | 12546-110-04 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | 12546-110-40 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | 12546-110-03 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | 12546-110-16 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | 12546-110-24 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | 12546-110-99 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | 12546-110-96 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | 12546-110-02 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | 12546-110-18 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | 12546-110-04 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 12546-110-40 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 12546-110-03 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 12546-110-16 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 12546-110-24 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 12546-110-99 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 12546-110-96 | 302b2466d912… | e7b80fea0513… |
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
- Honey Lemon
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| MENTHOL | 7.5 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| L7T10EIP3A | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| aec46410-ffb1-4db4-b232-82110c562f69 | Available on FDA.report |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 12546-110-00 | HallsHoney Lemon | 250 in 1 JAR | LOZENGE | 250 | 20 | |
| 12546-110-01 | HallsHoney Lemon | 140 in 1 BAG | LOZENGE | 140 | 20 | |
| 12546-110-02 | HallsHoney Lemon | 150000 in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK | LOZENGE | 150000 | 20 | |
| 12546-110-03 | HallsHoney Lemon | 2400 in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK | LOZENGE | 2400 | 20 | |
| 12546-110-04 | HallsHoney Lemon | 720 in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK | LOZENGE | 720 | 20 | |
| 12546-110-14 | HallsHoney Lemon | 14 in 1 PACKAGE | LOZENGE | 14 | 20 | |
| 12546-110-16 | HallsHoney Lemon | 16 in 1 BAG | LOZENGE | 16 | 20 | |
| 12546-110-18 | HallsHoney Lemon | 18 in 1 BAG | LOZENGE | 18 | 20 | |
| 12546-110-24 | HallsHoney Lemon | 24 in 1 BAG | LOZENGE | 24 | 20 | |
| 12546-110-30 | HallsHoney Lemon | 30 in 1 BAG | LOZENGE | 30 | 20 | |
| 12546-110-40 | HallsHoney Lemon | 40 in 1 BAG | LOZENGE | 40 | 20 | |
| 12546-110-80 | HallsHoney Lemon | 80 in 1 BAG | LOZENGE | 80 | 20 | |
| 12546-110-96 | HallsHoney Lemon | 96 in 1 BAG | LOZENGE | 96 | 20 | |
| 12546-110-99 | HallsHoney Lemon | 160 in 1 BAG | LOZENGE | 160 | 20 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| MENTHOL | ACTIVE INGREDIENT | L7T10EIP3A | HALLS HONEY LEMON (MENTHOL) LOZENGE [MONDELEZ GLOBAL LLC] | 3 | |
| MENTHOL | ACTIVE MOIETY | L7T10EIP3A | HALLS HONEY LEMON (MENTHOL) LOZENGE [MONDELEZ GLOBAL LLC] | 3 | |
| BETA CAROTENE | INACTIVE INGREDIENT | 01YAE03M7J | HALLS HONEY LEMON (MENTHOL) LOZENGE [MONDELEZ GLOBAL LLC] | 3 | |
| EUCALYPTUS OIL | INACTIVE INGREDIENT | 2R04ONI662 | HALLS HONEY LEMON (MENTHOL) LOZENGE [MONDELEZ GLOBAL LLC] | 3 | |
| HONEY | INACTIVE INGREDIENT | Y9H1V576FH | HALLS HONEY LEMON (MENTHOL) LOZENGE [MONDELEZ GLOBAL LLC] | 3 | |
| LECITHIN, SOYBEAN | INACTIVE INGREDIENT | 1DI56QDM62 | HALLS HONEY LEMON (MENTHOL) LOZENGE [MONDELEZ GLOBAL LLC] | 3 | |
| SUCRALOSE | INACTIVE INGREDIENT | 96K6UQ3ZD4 | HALLS HONEY LEMON (MENTHOL) LOZENGE [MONDELEZ GLOBAL LLC] | 3 | |
| SUCROSE | INACTIVE INGREDIENT | C151H8M554 | HALLS HONEY LEMON (MENTHOL) LOZENGE [MONDELEZ GLOBAL LLC] | 3 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | HALLS HONEY LEMON (MENTHOL) LOZENGE [MONDELEZ GLOBAL LLC] | 3 |
DailyMed Dashboard NDC Coverage#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Vapo Steam | VAPO STEAM | TOPCO ASSOCIATES, LLC | f216f69f-9580-25ac-e053-2995a90a5ac6 | 2026-01-14 | Warnings | M012 |
| Leader Vapor Ice Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE | Cardinal Health 110, LLC. dba Leader | f27bf0b2-25cc-474c-ab6b-f227ed3525fa | 2026-01-14 | Warnings | M012 |
| Sinus PE plus Allergy | CHLORPHENIRAMINE MALEATE AND PHENYLEPHRINE HCL | Walgreen Company | a15979d4-87bf-42e7-b1f2-783496072141 | 2026-01-13 | Warnings | M012 |
| Nighttime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | BETTER LIVING BRANDS LLC. | 41f4bf6d-f83c-92e4-e063-6394a90aebab | 2026-01-13 | Warnings | M012 |
| Allergy Relief | DIPHENHYDRAMINE HYDROCHLORIDE | HYVEE INC | 3e608643-1a74-b474-e063-6294a90ad2e0 | 2026-01-13 | Warnings | M012 |
| Severe Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | HYVEE INC | 462cbf3d-51b1-dab9-e063-6394a90a70ba | 2026-01-13 | Warnings | M012 |
| Pocket Farmacy | MENTHOL | Saje Natural Business Inc. | 4260542e-0980-4b0b-8177-1c9f2c53b5a6 | 2026-01-13 | Warnings | M012 |
| Sweet Comfort | MENTHOL | Saje Natural Business Inc. | cf13cccd-723d-4d61-8a5e-b36281605cc7 | 2026-01-13 | Warnings | M012 |
| Fortify | MENTHOL | Saje Natural Business Inc. | 0320a305-99d1-4909-94cc-cd6509ecb948 | 2026-01-13 | Warnings | M012 |
| Rolling Farmacy | MENTHOL | Saje Natural Business Inc. | a38765a9-22cd-4fc5-b5ab-c3cacbd52c74 | 2026-01-13 | Warnings | M012 |
| Home Farmacy | MENTHOL | Saje Natural Business Inc. | add35d10-b27a-4ae8-b2de-8a285aaef155 | 2026-01-13 | Warnings | M012 |
| Traveling Farmacy | MENTHOL | Saje Natural Business Inc. | 5b70f5aa-ed36-65ab-e053-2a91aa0a6777 | 2026-01-13 | Warnings | M012 |
| sinus plus allergy PE maximum strength | CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL | United Natural Foods, Inc. dba UNFI | 660d3c80-f249-41dd-aa93-a0b1e635ead0 | 2026-01-13 | Warnings | M012 |
| Chest Comfort | MENTHOL | Saje Natural Business Inc. | 8a3db169-6dd7-4dfd-8360-90315288f21b | 2026-01-12 | Warnings | M012 |
| Allergy Relief | DIPHENHYDRAMINE HCL | H E B | c9e977b6-fba6-49ea-9d80-b43b0842bbe1 | 2026-01-12 | Warnings | M012 |
| PE Sinus Congestion | PHENYLEPHRINE HCL | Topco Associates, LLC | 3264e291-7a0f-4e25-8390-ba441f22f650 | 2026-01-12 | Warnings | M012 |
| Childrens Allergy Relief | DIPHENHYDRAMINE HCL | CVS PHARMACY | 3f44cff6-240a-4a8d-aaa1-0da75a31a47b | 2026-01-12 | Warnings | M012 |
| Suphedrine PE Sinus Congestion Non-Drowsy | PHENYLEPHRINE HCL | ARMY AND AIR FORCE EXCHANGE SERVICE | b9122fd0-0bed-4302-9bbe-cd6a46d29818 | 2026-01-12 | Warnings | M012 |
| Sinu-Phen Plus Sinus Pain and Pressure | ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE | Wildman Business Group | c66e0b52-5531-4a84-ae90-8a26d27df1ec | 2026-01-12 | Warnings | M012 |
| SU PHEDRINE PE SINUS CONGESTION | PHENYLEPHRINE HCL | Salado Sales, Inc. | ba075ff7-4e26-4856-8335-0c7dd4e198ea | 2026-01-12 | Warnings | M012 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1250191 | Halls 7.5 MG Oral Lozenge | PSN | aec46410-ffb1-4db4-b232-82110c562f69 | 20 |
| 1250189 | menthol 7.5 MG Oral Lozenge | PSN | aec46410-ffb1-4db4-b232-82110c562f69 | 20 |
| 1250191 | menthol 7.5 MG Oral Lozenge [Halls] | SBD | aec46410-ffb1-4db4-b232-82110c562f69 | 20 |
| 1250189 | menthol 7.5 MG Oral Lozenge | SCD | aec46410-ffb1-4db4-b232-82110c562f69 | 20 |
| 1250191 | Halls 7.5 MG Oral Lozenge | SY | aec46410-ffb1-4db4-b232-82110c562f69 | 20 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 12546-110-00 | 12546011000 | 250 LOZENGE in 1 JAR (12546-110-00) | 250 lozenge | 2022-07-06 | 0000-00-00 | No | No | Current |
| 12546-110-01 | 12546011001 | 140 LOZENGE in 1 BAG (12546-110-01) | 140 lozenge | 2023-04-10 | No | No | Current | |
| 12546-110-02 | 12546011002 | 150000 LOZENGE in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK (12546-110-02) | 150000 lozenge | 2019-12-02 | 0000-00-00 | No | No | Current |
| 12546-110-03 | 12546011003 | 2400 LOZENGE in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK (12546-110-03) | 2400 lozenge | 2019-12-02 | 0000-00-00 | No | No | Current |
| 12546-110-04 | 12546011004 | 720 LOZENGE in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK (12546-110-04) | 720 lozenge | 2019-12-02 | 0000-00-00 | No | No | Current |
| 12546-110-14 | 12546011014 | 14 LOZENGE in 1 PACKAGE (12546-110-14) | 14 lozenge | 2019-03-24 | 0000-00-00 | No | No | Current |
| 12546-110-16 | 12546011016 | 16 LOZENGE in 1 BAG (12546-110-16) | 16 lozenge | 2019-03-24 | 0000-00-00 | No | No | Current |
| 12546-110-18 | 12546011018 | 18 LOZENGE in 1 BAG (12546-110-18) | 18 lozenge | 2019-03-24 | 0000-00-00 | No | No | Current |
| 12546-110-24 | 12546011024 | 24 LOZENGE in 1 BAG (12546-110-24) | 24 lozenge | 2019-12-02 | 0000-00-00 | No | No | Current |
| 12546-110-30 | 12546011030 | 30 LOZENGE in 1 BAG (12546-110-30) | 30 lozenge | 2019-03-24 | 0000-00-00 | No | No | Current |
| 12546-110-40 | 12546011040 | 40 LOZENGE in 1 BAG (12546-110-40) | 40 lozenge | 2019-03-24 | 0000-00-00 | No | No | Current |
| 12546-110-80 | 12546011080 | 80 LOZENGE in 1 BAG (12546-110-80) | 80 lozenge | 2019-03-24 | 0000-00-00 | No | No | Current |
| 12546-110-96 | 12546011096 | 96 LOZENGE in 1 BAG (12546-110-96) | 96 lozenge | 2019-03-24 | 0000-00-00 | No | No | Current |
| 12546-110-99 | 12546011099 | 160 LOZENGE in 1 BAG (12546-110-99) | 160 lozenge | 2019-03-24 | 0000-00-00 | No | No | Current |