Allergy
- Product NDC
- 69168-277
- 11-digit product format
- 691680277
- Labeler code
- 69168
- Product ID
- 69168-277_aa78dfc9-7395-4619-9e32-91ea3b546ee9
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Chlorpheniramine maleate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Allegiant Health
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2014-12-15
- 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
- 2026-12-31
- Current FDA listing
- Yes
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
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| CHLORPHENIRAMINE MALEATE | 4 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| V1Q0O9OJ9Z | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1363309 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 4305ad50-d2a5-4d3e-9d92-cbf26e856a16 | Available on FDA.report |
DailyMed Product Concepts#
| 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 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 69168-277-93 | 2020-03-13 | C162847 | 48780-1 | 9d75b9d0-1cde-f424-e053-dadaa90a57ce | Drug Facts |
| 69168-277-93 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-1cde-f424-e053-dadaa90a57ce | Drug Facts |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 69168-277-93 | Allergy | 24 in 1 BLISTER PACK | TABLET | 24 | 5 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| CHLORPHENIRAMINE MALEATE | ACTIVE INGREDIENT | V1Q0O9OJ9Z | ALLERGY (CHLORPHENIRAMINE MALEATE) TABLET [ALLEGIANT HEALTH] | 1 | |
| CHLORPHENIRAMINE | ACTIVE MOIETY | 3U6IO1965U | ALLERGY (CHLORPHENIRAMINE MALEATE) TABLET [ALLEGIANT HEALTH] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | ALLERGY (CHLORPHENIRAMINE MALEATE) TABLET [ALLEGIANT HEALTH] | 1 | |
| D&C YELLOW NO. 10 | INACTIVE INGREDIENT | 35SW5USQ3G | ALLERGY (CHLORPHENIRAMINE MALEATE) TABLET [ALLEGIANT HEALTH] | 1 | |
| LACTOSE | INACTIVE INGREDIENT | J2B2A4N98G | ALLERGY (CHLORPHENIRAMINE MALEATE) TABLET [ALLEGIANT HEALTH] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | ALLERGY (CHLORPHENIRAMINE MALEATE) TABLET [ALLEGIANT HEALTH] | 1 | |
| STEARIC ACID | INACTIVE INGREDIENT | 4ELV7Z65AP | ALLERGY (CHLORPHENIRAMINE MALEATE) TABLET [ALLEGIANT HEALTH] | 1 |
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 |
|---|---|---|---|---|---|---|
| Good Neighbor Pharmacy Childrens Allergy | DIPHENHYDRAMINE HYDROCHLORIDE | Amerisource Bergen | b173cc2c-7c4c-4f9e-a920-c71bc256ec1e | 2024-07-18 | Warnings | M012 |
| ALLERGY | CHLORPHENIRAMINE MALEATE | A-S Medication Solutions | b199b5ee-fff3-4746-be68-a04060586f8e | 2024-07-18 | Warnings | M012 |
| Allergy | DIPHENHYDRAMINE HCL | H E B | 2d1715b3-b1cf-455d-9909-f6d58c97db40 | 2024-07-18 | Warnings | M012 |
| careone allergy relief | DIPHENHYDRAMINE HYDROCHLORIDE | American Sales Company | ed4038fc-ab39-4567-9961-2b390b91b126 | 2024-07-17 | Warnings | M012 |
| Topcare childrens allergy | DIPHENHYDRAMINE HYDROCHLORIDE | Topco Associates LLC | 6b784cde-3152-4421-a825-dd1fc601aa7a | 2024-07-17 | Warnings | M012 |
| Mucus Relief Severe Congestion and Cough Maximum Strength | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Walgreens | 4c6b6379-3a7f-4507-a792-7b69a7f3ba82 | 2024-07-17 | Warnings | M012 |
| Mucus Relief Cold Flu Sore Throat Maximum Strength | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Walgreens | 04defcf6-e20e-402b-b725-d9394a0146b1 | 2024-07-16 | Warnings | M012 |
| basic care allergy relief | DIPHENHYDRAMINE HYDROCHLORIDE | Amazon.com Services LLC | 7d237d37-21c7-476d-a8b7-d91ea1b472ee | 2024-07-16 | Warnings | M012 |
| Berkley and Jensen Allergy Relief | DIPHENHYDRAMINE HYDROCHLORIDE | BJWC | b52fc311-8853-4116-941b-8be35456abba | 2024-07-16 | Warnings | M012 |
| Mucus Relief All In One Daytime Nighttime Cold Flu Maximum Strength | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL, ACETAMINOPHEN, DIPHENHYDRAMINE HCL PHENYLEPHRINE HCL | Walgreens | 0b9a4438-7d13-484c-a614-2dedc24974dc | 2024-07-16 | Warnings | M012 |
| allergy | DIPHENHYDRAMINE HYDROCHLORIDE | Publix Super Markets Inc | 23a98385-28cc-4fac-8c87-b3ced8106532 | 2024-07-16 | Warnings | M012 |
| Walgreens Moisturizing Ultra Fine Mist with Aloe | 0.05% OXYMETAZOLINE | Walgreens Company | aad01028-cbe0-4c10-adbc-d157bfa5af09 | 2024-07-16 | Warnings | M012 |
| Basic Care severe cold and cough | ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE | Amazon.com Services LLC | 924bf427-b054-46af-b341-ff162946cd58 | 2024-07-15 | Warnings | M012 |
| Maximum Strength Cold Tabs | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | JHK DBA American Safety & First Aid | e7d4fe9a-eb09-4266-90c9-290f61ce6ad0 | 2024-07-15 | Warnings | M012 |
| ACTIDOM DA | CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE | ACTIPHARMA, LLC | 7797c22e-ffeb-4798-9fb6-aa64cf077ba7 | 2024-07-15 | Warnings | M012 |
| Nighttime severe cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | TARGET CORPORATION | 1cf3064d-4ddd-63b9-e063-6294a90aa547 | 2024-07-11 | Warnings | M012 |
| Daytime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HCL | TARGET CORPORATION | 1ccbdb53-3f70-28da-e063-6394a90a9ae0 | 2024-07-09 | Warnings | M012 |
| AXIV Allergy Relief | DIPHENHYDRAMINE HYDROCHLORIDE | VIVUNT PHARMA LLC | 1cd2a6f1-31ad-e507-e063-6394a90aba58 | 2024-07-09 | Warnings | M012 |
| Poly Hist Forte | DOXYLAMINE SUCCINATE AND PHENYLEPHRINE HYDROCHLORIDE | Poly Pharmaceuticals, Inc. | 8aa0015b-8fc1-7951-e053-2a95a90a8e72 | 2024-07-09 | Warnings | M012 |
| DECONEX DMX | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Poly Pharmaceuticals, Inc. | 8aab8e5c-1633-2e5a-e053-2a95a90adcc5 | 2024-07-09 | Warnings | M012 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1363309 | chlorpheniramine maleate 4 MG Oral Tablet | PSN | 4305ad50-d2a5-4d3e-9d92-cbf26e856a16 | 5 |
| 1363309 | chlorpheniramine maleate 4 MG Oral Tablet | SCD | 4305ad50-d2a5-4d3e-9d92-cbf26e856a16 | 5 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 69168-277-93 | 69168027793 | 24 TABLET in 1 BLISTER PACK (69168-277-93) | 24 tablet | 2014-12-15 | 0000-00-00 | No | No | Current |