BENZEDREX
- Product NDC
- 0225-0610
- 11-digit product format
- 002250610
- Labeler code
- 0225
- Product ID
- 0225-0610_ec979cf7-fbd0-b974-e053-2995a90aec84
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- PROPYLHEXEDRINE
- Dosage form
- INHALANT
- Route
- NASAL
- Labeler
- BF ASCHER AND CO INC
- Application
- M012
- Marketing category
- OTC MONOGRAPH FINAL
- Marketing start
- 2014-09-19
- Marketing end
- 0000-00-00
- Substance
- PROPYLHEXEDRINE
- Active strength
- 250 mg/1
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
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 product | product | 0225-0610 | D | Discontinued by firm | 2026-10-21 | ||
| excluded package | package | 0225-0610 | 0225-0610-23 | D | Discontinued by firm | 2026-10-21 |
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 | Dataset | Scope | Package NDC | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded product | product | d630ba8d3edf… | 732f749b63fb… | |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 0225-0610-23 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded product | product | f5e01cc5f278… | a2eaf40c39c3… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 0225-0610-23 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded product | product | 2ef7874e63bc… | 57b86245f4fa… | |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 0225-0610-23 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded product | product | a1b67e2a42f9… | c4cf2c586c0d… | |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 0225-0610-23 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded product | product | cfe11265f3b6… | 090c488252e2… | |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 0225-0610-23 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded product | product | cdf11ea48f46… | ba0047e9e063… | |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 0225-0610-23 | cdf11ea48f46… | ba0047e9e063… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0225-0610-23 | EA - Each | 0225-0610 | a5e71a11-6b7c-43aa-b69e-cb0fed8ae8db | 1 | 2014-10-03 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| PROPYLHEXEDRINE | ACTIVE INGREDIENT | LQU92IU8LL | BENZEDREX 09-19-2014 (PROPYLHEXEDRINE) INHALANT [BF ASCHER AND CO INC] | 2 | |
| PROPYLHEXEDRINE | ACTIVE MOIETY | LQU92IU8LL | BENZEDREX 09-19-2014 (PROPYLHEXEDRINE) INHALANT [BF ASCHER AND CO INC] | 2 | |
| LAVENDER OIL | INACTIVE INGREDIENT | ZBP1YXW0H8 | BENZEDREX 09-19-2014 (PROPYLHEXEDRINE) INHALANT [BF ASCHER AND CO INC] | 2 | |
| MENTHOL | INACTIVE INGREDIENT | L7T10EIP3A | BENZEDREX 09-19-2014 (PROPYLHEXEDRINE) INHALANT [BF ASCHER AND CO INC] | 2 |
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 |
|---|---|---|---|---|---|---|
| Signature Care Original | OXYMETAZOLINE HYDROCHLORIDE | SAFEWAY, INC. | f7ad687b-dcaf-928c-e053-6294a90a6abe | 2025-10-16 | Warnings | M012 |
| Daytime Nighttime Cold Flu Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | Care One (Retail Business Services, LLC.) | 90ccb29c-9967-46cb-a409-e440344e1a1a | 2025-10-15 | Warnings | M012 |
| Robitussin Childrens Honey Day Night DM Value Pack | DEXTROMETHORPHAN HBR, GUAIFENESIN, DOXYLAMINE SUCCINATE | Haleon US Holdings LLC | f9999875-3433-4052-a628-39539d373216 | 2025-10-15 | Warnings | M012 |
| Robitussin Day and Night Cough Relief Value Pack | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, CHLORPHENIRAMINE MALEATE | Haleon US Holdings LLC | 4029eccd-5443-4ae2-9232-2a1d922798f8 | 2025-10-15 | Warnings | M012 |
| EndaCof DM | BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE AND PHENYLEPHRINE HYDROCHLORIDE | Larken Laboratories, Inc. | c68ea55a-8b9a-4a70-8b5c-1a2736651813 | 2025-10-15 | Warnings | M012 |
| DURATUSS DM | DEXBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE | Poly Pharmaceuticals, Inc. | 413a3951-d704-f14b-e063-6394a90a06dc | 2025-10-15 | Warnings | M012 |
| LoHist DM | BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE AND PHENYLEPHRINE HYDROCHLORIDE | Larken Laboratories, Inc. | 29730dab-fa09-4351-9b36-0359ba4f7744 | 2025-10-15 | Warnings | M012 |
| M-END DMX | DEXBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PSEUDOEPHEDRINE HYDROCHLORIDE | R. A. McNeil Company | ee1fae2e-3a21-4487-9989-c7620a4a7056 | 2025-10-15 | Warnings | M012 |
| Chlo Tuss | CHLOPHEDIANOL HYDROCHLORIDE, DEXBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE | R.A. McNeil Company | 43610aaa-8b94-40d5-ae09-3d75bd2317c8 | 2025-10-15 | Warnings | M012 |
| Chlo Hist | CHLOPHEDIANOL HYDROCHLORIDE, DEXBROMPHENIRAMINE MALEATE | R. A. McNeil Company | d046f4ba-5753-4ed5-a924-0b66fd116781 | 2025-10-15 | Warnings | M012 |
| Daytime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Care One (Retail Business Services, LLC.) | 6ca7372b-50c4-4b15-b133-fefa35525ade | 2025-10-15 | Warnings | M012 |
| Extra Strength Sinus Relief Nasal Decongestant | PHENYLEPHRINE HYDROCHLORIDE | CARDINAL HEALTH | 0d8a009c-30b5-4f12-90bd-f8aa1110243f | 2025-10-14 | Warnings | M012 |
| Tussin DM Cough plus Chest Congestion | DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN | Cardinal Health 110, Inc. DBA LEADER | 9d11f443-c93d-44e8-b5a3-2677b7b11212 | 2025-10-14 | Warnings | M012 |
| Rompe Pecho SF | GUAIFENESIN | Efficient Laboratories, Inc. | 31ff48fc-9603-413c-ab7c-2598b3e08f9c | 2025-10-14 | Warnings | M012 |
| Rompe Pecho DM | DEXTROMETHORPHAN HBR, GUAIFENESIN | Efficient Laboratories Inc | d108c712-bc36-41d7-9ccd-720496b5599e | 2025-10-14 | Warnings | M012 |
| Rompe Pechito DM for Kids | DEXTROMETHORPHAN HBR, GUAIFENESIN | Efficient Laboratories Inc | 004d12e1-6e3d-84c8-e063-6394a90aa653 | 2025-10-14 | Warnings | M012 |
| VANACOF CP Allergy / Cough | CHLOPHEDIANOL HCL, PYRILAMINE MALEATE | GM Pharmaceuticals, INC | 0bdea30a-39da-6611-e063-6394a90aa4cf | 2025-10-14 | Warnings | M012 |
| VANACOF | CHLOPHEDIANOL HYDROCHLORIDE, DEXCHLORPHENIRAMINE MALEATE, AND PSEUDOEPHEDRINE HYDROCHLORIDE | GM Pharmaceuticals, INC | cf3886ab-62b3-497a-a587-18cbfbaf3634 | 2025-10-14 | Warnings | M012 |
| Sugar Free Cherry Fishermans Friend Menthol Cough Suppressant | MENTHOL | Lofthouse of Fleetwood, Ltd. | 42d4bafb-b630-487e-b63d-13ad37a59454 | 2025-10-14 | Warnings | M012 |
| SUPRESS A | DEXBROMOPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Dextrum Laboratories, Inc | 410c19f7-213d-cd99-e063-6294a90af5a3 | 2025-10-13 | Warnings | M012 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0225-0610-23 | 00225061023 | 1 INHALANT in 1 INHALER (0225-0610-23) | 1 inhalant | 2014-09-19 | 0000-00-00 | No | No | Current |