allergy
- Product NDC
- 41250-479
- 11-digit product format
- 412500479
- Labeler code
- 41250
- Product ID
- 41250-479_4ec300ab-2512-4a5f-ba03-ea3ea2666056
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Diphenhydramine Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Meijer Distribution Inc
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 1991-09-06
- Substance
- DIPHENHYDRAMINE HYDROCHLORIDE
- Active strength
- 25 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.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded package | package | 41250-479 | 41250-479-53 | D | Discontinued by firm | 2026-10-20 | |
| excluded package | package | 41250-479 | 41250-479-62 | D | Discontinued by firm | 2026-10-20 | |
| excluded package | package | 41250-479 | 41250-479-67 | D | Discontinued by firm | 2026-10-20 |
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 | 41250-479-62 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | 41250-479-67 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | 41250-479-53 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | 41250-479-62 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | 41250-479-67 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | 41250-479-53 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 41250-479-62 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 41250-479-67 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 41250-479-53 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | 41250-479-62 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | 41250-479-67 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | 41250-479-53 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | 41250-479-62 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | 41250-479-67 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | 41250-479-53 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | 41250-479-62 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | 41250-479-67 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | 41250-479-53 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 41250-479-62 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 41250-479-67 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 41250-479-53 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | 41250-479-62 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | 41250-479-67 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | 41250-479-53 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 41250-479-62 | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 41250-479-67 | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 41250-479-53 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | 41250-479-62 | ad56d346431e… | cc804d4bbf1e… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | 41250-479-67 | ad56d346431e… | cc804d4bbf1e… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | 41250-479-53 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | 41250-479-62 | 367a005e9d99… | 383a685ebd0f… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | 41250-479-67 | 367a005e9d99… | 383a685ebd0f… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | 41250-479-53 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | 41250-479-53 | 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
- allergy
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| DIPHENHYDRAMINE HYDROCHLORIDE | 25 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| TC2D6JAD40 | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1049630 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| f1e83e43-011c-4470-bd55-fb2818a9fc84 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 0e2e0f88-b076-afe1-4bdd-32bca4375bec | Product name | 3 | 20250127 |
| 3e48c9c4-918d-5d23-2f0b-d2398b06be54 | Product name | 1 | 20140508 |
| 865c72dd-0d94-daac-f728-ddd4ded2a79e | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 41250-479-53 | allergy | 1 in 1 BLISTER PACK | TABLET | 1 | 6 | |
| 41250-479-53 | allergy | 12 in 1 CARTON | TABLET | 12 | 6 | |
| 41250-479-62 | allergy | 24 in 1 CARTON | TABLET | 24 | 6 | |
| 41250-479-62 | allergy | 1 in 1 BLISTER PACK | TABLET | 1 | 6 | |
| 41250-479-67 | allergy | 48 in 1 CARTON | TABLET | 48 | 6 | |
| 41250-479-67 | allergy | 1 in 1 BLISTER PACK | TABLET | 1 | 6 | |
| 41250-479-78 | allergy | 1 in 1 CARTON | TABLET | 1 | 6 | |
| 41250-479-78 | allergy | 100 in 1 BOTTLE | TABLET | 100 | 6 |
DailyMed Socrata Ingredients#
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 |
|---|---|---|---|---|---|---|
| Childrens Allergy Relief | DIPHENHYDRAMINE HCL | Marc Glassman, Inc. | e916ef86-ca73-42dd-83dc-6033f56d96f2 | 2025-12-19 | Warnings | M012 |
| Original Night-Time MULTI-SYMPTOM COLD/FLU RELIEF | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | Discount Drug Mart | e243033b-6603-4c3e-a330-e7c7de51f69d | 2025-12-19 | Warnings | M012 |
| CHILDRENS ALLERGY | DIPHENHYDRAMINE HYDROCHLORIDE | Discount Drug Mart | 6fa4f913-de83-4175-9dad-0dedab5b69a1 | 2025-12-19 | Warnings | M012 |
| Day-Time COLD/FLU RELIEF | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HCL | Discount Drug Mart | 426db906-9aa4-448f-a361-09c1516efc25 | 2025-12-19 | Warnings | M012 |
| MAXIUM STRENGTH SEVERE CONGESTION and COUGH MAX | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Discount Drug Mart | f17385bc-82bb-4183-a4c9-067d8afb3757 | 2025-12-19 | Warnings | M012 |
| MAXIUM STRENGTH DM MAX | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | Discount Drug Mart | 9654fdcd-d660-471f-bc5d-aa7dead7a4a8 | 2025-12-19 | Warnings | M012 |
| Night Time Multi-Symptom Cold and Flu Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | Discount Drug Mart | 8148c2b1-f6ec-4597-8e18-a6597cda5705 | 2025-12-19 | Warnings | M012 |
| Allergy Relief | DIPHENHYDRAMINE HCL 25 MG | NUVICARE LLC | 621ba20e-75c5-42fb-9692-7800f764c978 | 2025-12-19 | Warnings | M012 |
| Nasal Decongestant PE | PHENYLEPHRINE HCL 10 MG | NUVICARE LLC | 4cde41dd-a0a7-45e7-aff3-ee9402dfdff2 | 2025-12-19 | Warnings | M012 |
| COMBINATION PACK TopCare health DayTime SEVERE and NiteTime SEVERE Cold and Flu Relief SOFTGELS - 24 ct | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE | Topco Associates LLC | ceb27ff3-cf42-44f9-9ee6-8ea86a0cbe3e | 2025-12-19 | Warnings | M012 |
| NeoTuss S/F Grape-Menthol Flavor | GUAIFENESIN, DEXTROMETHORPHAN HBR | DORAL PHARMAMEDICS INC dba A.G. Marin Pharmaceuticals | 2f3df82c-1926-5238-e063-6294a90a7bbf | 2025-12-18 | Warnings | M012 |
| NeoTuss S/F Grape-Menthol Flavor | GUAIFENESIN, DEXTROMETHORPHAN HBR | DORAL PHARMAMEDICS INC dba A.G. Marin Pharmaceuticals | 2fac3425-32f0-38d6-e063-6394a90a6e7a | 2025-12-18 | Warnings | M012 |
| NAFASOLINA | NAPHAZOLINE HYDROCHLORIDE | Doral Pharmamedics Inc DBA AG Marin Pharmaceuticals | 30cade3d-208f-8594-e063-6394a90ad2a0 | 2025-12-18 | Warnings | M012 |
| Honey Lemon Flavor Cough Drop | HONEY LEMON FLAVOR COUGH DROP | Army & Air Force Exchange Service | 20ac8a20-206c-0024-e063-6394a90a9d06 | 2025-12-18 | Warnings | M012 |
| Menthol Flavor Cough Drop | MENTHOL FLAVOR COUGH DROP | Army & Air Force Exchange Service | 20ace10f-4257-b20e-e063-6394a90a3c7b | 2025-12-18 | Warnings | M012 |
| NeoTuss Plus | DEXTROMETHORPHAN HBR, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL | DORAL PHARMAMEDICS INC dba A.G. Marin Pharmaceuticals | 2fabd782-14dc-1d1b-e063-6394a90af428 | 2025-12-18 | Warnings | M012 |
| NeoTuss Plus | DEXTROMETHORPHAN HBR, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL | DORAL PHARMAMEDICS INC dba A.G. Marin Pharmaceuticals | 2f3c6b38-7236-899b-e063-6294a90aabde | 2025-12-18 | Warnings | M012 |
| QUALITY CHOICE Cough Drops Black Cherry SUGAR FREE | MENTHOL | Chain Drug Marketing Association, Inc. | 8f6ee01c-baad-489f-b2fd-0ef506916ee4 | 2025-12-18 | Warnings | M012 |
| menthol cough drops | MENTHOL | Meijer | 5baeaff7-172c-187a-e053-2a91aa0ab165 | 2025-12-18 | Warnings | M012 |
| Menthol Cough Drops | MENTHOL | Meijer Distribution Inc. | 3bee752a-4141-1f5b-e054-00144ff8d46c | 2025-12-18 | Warnings | M012 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1049630 | diphenhydrAMINE HCl 25 MG Oral Tablet | PSN | f1e83e43-011c-4470-bd55-fb2818a9fc84 | 6 |
| 1049630 | diphenhydramine hydrochloride 25 MG Oral Tablet | SCD | f1e83e43-011c-4470-bd55-fb2818a9fc84 | 6 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 41250-479-53 | 41250047953 | 12 BLISTER PACK in 1 CARTON (41250-479-53) > 1 TABLET in 1 BLISTER PACK | 12 blister pack | 2018-07-06 | 0000-00-00 | No | No | Current |
| 41250-479-62 | 41250047962 | 24 BLISTER PACK in 1 CARTON (41250-479-62) > 1 TABLET in 1 BLISTER PACK | 24 blister pack | 1991-09-06 | 0000-00-00 | No | No | Current |
| 41250-479-67 | 41250047967 | 48 BLISTER PACK in 1 CARTON (41250-479-67) > 1 TABLET in 1 BLISTER PACK | 48 blister pack | 1998-03-12 | 0000-00-00 | No | No | Current |
| 41250-479-78 | 41250047978 | 1 BOTTLE in 1 CARTON (41250-479-78) / 100 TABLET, FILM COATED in 1 BOTTLE | 1 bottle | 1993-05-27 | 0000-00-00 | No | No | Current |